Liste der Antigen-Tests zum direkten Erregernachweis des Coronavirus SARS-CoV-2, die Gegenstand des Anspruchs nach § 1 Satz 1 gemäß "Dritte Verordnung zur Änderung der Verordnung zum Anspruch auf bestimmte Testungen für den Nachweis des Vorliegens einer Infektion mit dem Coronavirus SARS-CoV-2 (Coronavirus-Testverordnung – TestV)" sind.
Quelle: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Stand 30.10.2020
Alle Daten gemäß Übermittlung des Herstellers, verbindlich sind ausschließlich die Angaben in den jeweiligen Gebrauchsinformationen.
Alphabetisch sortiert ("Hersteller Name")
Hersteller Name | Hersteller Stadt | Hersteller Land | Deutsche/r Vertreiber | EU Bevollmächtigter Name | EU Bevollmächtigter Stadt | EU Bevollmächtigter Land | Handelsname des Tests | Artikelnummer | Sensitivität % | 95%iges Vertrauensintervall (Sensitivität) | Spezifität % | 95%iges Vertrauensintervall (Spezifität) | Gebrauchsanweisung |
Abbott Rapid Diagnostics Jena GmbH | Jena | DE | Abbott Rapid Diagnostics Germany GmbH | Panbio™ COVID-19 Ag Rapid Test Device | 41FK10 | 91,4 | 85,5 - 95,5 | 99,8 | 98,8 - 100 | https://ensur.invmed.com/ensur/contentAction.aspx?key=ensur.547995.S2R4E4A3.20201014.11230.4318006 | |||
Acro Biotech Inc. | Rancho Cucamonga | US | Aidian Germany GmbH | MedNet GmbH | Münster | DE | Acro COVID-19 and Influenza A+B Antigen Combo Rapid Test | ICIC-ACO525 | 90,4 | 79 - 96,8 | 99,5 | 97,2 - 99,9 | https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Acro/146300304_ICIC-525_ACRO_CE_EN_PI.pdf |
Acro Biotech Inc. | Rancho Cucamonga | US | Aidian Germany GmbH | MedNet GmbH | Münster | DE | Acro COVID-19 Antigen Rapid Test | INCP-ACO502 | 90,4 | 79 - 96,8 | 99,5 | 97,2 - 99,9 | https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Acro/146300204_ICOV-502_ACRO_CE_EN_PI.pdf |
AMEDA Labordiagnostik GmbH | Graz | AT | DIM LabService GmbH & Co. KG | AMP Rapid Test SARS-CoV-2 Ag | RT2951 / RT 2952 | 97,3 | 90,0 - 99,8 | 100 | 96,6 - 100 | ||||
Azure Biotech,Inc | Houston,Texas | US | NanoRepro AG | Lotus NL B.V. | The Hague | NL | Dia Sure COVID-19 Antigen Rapid Test Device | 94,3 | 84,6 - 98,1 | 99,1 | 98,4 - 99,5 | https://www.nanorepro.com/media/nanorepro-covid-19-antigen-ab-packungsbeilage.pdf | |
Beijing Beier Bioengineering Co., Ltd. | Beijing | CN | High Lux International Trading GmbH | MedNet EC-REP GmbH | Münster | DE | COVID-19 Antigen Rapid Test Kit | 96,5 | 93,7 - 99,3 | 99,7 | 99,0 - 100 | http://www.beierbio.com/en/uploadfile/2020-10-23/4976409d-2b1c-4f47-8495-07d8e83b5a40.pdf | |
Beijing Hotgen Biotech Co., Ltd | Beijing | CN | fameditec GmbH | MedNet GmbH | Münster | DE | CORA CHECK-19 | 4,27E+12 | 96,62 | 99,76 | https://www.fameditec.de/cora-check-19-gebrauchsanweisung | ||
Beijing Hotgen Biotech Co.,Ltd | Peking | CN | Dr. Grob Healthcare | MedNet GmbH | Münster | DE | Coronavirus 2019-nCoV Antigen Test | ANTIGEN97 | 97,1 | 93,80 - 98,93 | 99,76 | 98,65 - 99,99 | http://www.dr-grob.com/antigen97 |
Beijing Lepu Medical Technology Co., Ltd | Beijing | CN | Frohvogel Medizinprodukte UG | Lepu Medical (Europe) Cooperatief U.A. | Heerenveen | NL | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | N/A | 92 | 83,63 - 96,28 | 99,26 | 95,92 - 99,87 | http://www.frohvogel.de/ |
Beijing Lepu Medical Technology Co., Ltd | Beijing | CN | Deutsche HansaGT GmbH | Lepu Medical (Europe) Cooperatief U.A | Heerenveen | NL | Lepu SARS-CoV-2 Antigen Rapid Test Kit | 92 | 83,63 - 96,28 | 99,26 | 95,92 - 99,87 | https://cdn.website-editor.net/0b7a57acfd0e45f9b8a3f3bed5863f21/files/uploaded/anleitung%2520Lepu.pdf | |
Beijing Lepu Medical Technology Co., Ltd | Beijing | CN | Icon Medlab GmbH | Lepu Medical (Europe) Cooperatief U.A. | Heerenveen | NL | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal GoldImmunochromatography) | 92 | 83,63 - 96,28 | 99,26 | 95,92 - 99,87 | https://www.iconmedlab.com/service | |
Beijing Lepu Medical Technology Co., Ltd | Beijing | CN | Temiz AVZ GmbH | Lepu Medical (Europe) Cooperatief U.A. | Heerenveen | NL | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | 92 | 83,63 - 96,28 | 99,26 | 95,92 - 99,87 | https://www.antiviruszentrum.de/downloads/gebrauchsanweisung | |
Biohit Healthcare (Hefei) Co., Ltd. | Hefei | CN | ScheBo Biotech AG | ScheBo Biotech AG | Gießen | DE | SARS-CoV-2 Antigen Rapid Test Kit | 34 | 96,77 | 88,83 - 99,61 | 98,94 | 96,21 - 99,87 | https://www.schebo.de/produkte/artikel-34-testanleitung/ |
Bionote, Inc. | Hwaseong-si, Gyeonggi-do | KR | Concile GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | NowCheck COVID-19 Ag Test | DE/CA70/40838/156134 | 89,2 | 81,7 - 93,9 | 97,6 | 95,1 - 98,8 | https://bit.ly/3191UVD |
Biosynex Swiss SA | Freiburg | CH | Aidian Germany GmbH | FR | BIOSYNEX COVID-19 Ag BSS | SW40006 | 96 | 93,6 - 98,4 | 100 | 100 - 100 | https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Biosynex/IFU_SW40006_DE_V03202008R03.pdf | ||
Boditech Med Inc. | Chuncheon-si, Gang-won-do | KR | gurumB GmbH | Obelis s.a | Brussels | BE | ichroma™ COVI-19 Ag | 90,4 | 83,2 - 94,7 | 97,6 | 91,5 - 99,3 | https://www.gurumb.eu/ichroma-ii-covid-19-ag-de-gebrauchsanweisung | |
BTNX INC. | Ontario L3R 4G7 | CA | NanoRepro AG | MDSS GmbH | Hannover | DE | Rapid Response COVID-19 Antigen Rapid Test Device | COV-19C25 | 94,55 | 83,93 - 98,58 | 100 | 97,1 - 100 | https://www.nanorepro.com/media/nanorepro-covid-19-antigen-packungsbeilage.pdf |
CerTest Biotec S.L. | Zaragoza | ES | bestbion dx GmbH | DE | SARS-CoV-2 + Flu A + B + RSV Quad Kassettenschnelltest inkl. Tupfer + pos. Kontrolle | 03B11044 | 92,9 | 76,5 – 99,1 | 99,6 | 97,6 – 100,0 | https://www.certest.es/wp-content/uploads/2020/09/QUAD_IU-SV86-v.01.pdf | ||
CerTest Biotec S.L. | Zaragoza | ES | bestbion dx GmbH | DE | SARS-CoV-2 Kassettenschnelltest inkl. pos. Kontrolle | 03B11041 | 92,9 | 76,5 – 99,1 | 99,6 | 97,6 – 100,0 | https://www.certest.es/wp-content/uploads/2020/09/Web_SARS-CoV-2_SINGLE_IU-SC8-v.02.1.pdf | ||
Devidia GmbH | Weimar | DE | DEDIATEST 2019-nCoV Antigen Rapid Test | 2.13.1.555 | 96,5 | 92,6 - 98,7 | 99,5 | 97,2 - 99,9 | https://www.testyounow.com/instructions | ||||
Edinburgh Genetics Limited | Penicuik | GB | Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit | 91,2 | 90 - 92,4 | 98,6 | 97,8 - 99,4 | https://www.eggenetics.com/wp-content/uploads/2020/10/Edinburgh-Genetics-ActivXpress-COVID-19-Antigen-Complete-Testing-Kit-German-v1.6.pdf | |||||
Fujirebio Inc. | Shinjuku-ku,Tokyo | JP | Fujirebio Germany GmbH | Fujirebio Europe N.V. | Gent | BE | Lumipulse G SARS-CoV-2 Ag | 260340 | 91,7 | 74,2 - 97,7 | 97,3 | 94,8 - 98,6 | http://www.e-labeling.eu/FRI |
GenBody Inc. | Cheonan-si | KR | Meridian Bioscience Europe SRL | MT Promedt Consulting GmbH | Sankt ingbert | DE | GenBody COVID-19 Ag | Cat. No.: COVAG025 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | |
GenBody Inc. | Chungcheongnam-do | KR | Preventor µTBC GmbH | Preventor µTBC GmbH | Pfungstadt | DE | GenBody Influenza/COVID-19 Multi Ag Schnelltest | PRVCVIFG010-25 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | http://www.genbody.co.kr |
GenBody Inc. | Seobuk-gu, Cheonan-si, Chungcheongnam | KR | IVC Pragen GmbH | MT Promedt Consulting GmbH | St.Ingbert | DE | GenBody-COVID-19 Ag | COVAG025 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | http://www.ivc-pragen.com\ivd |
GenBody Inc. | Seobuk-gu, Cheonan-si, Chungcheongnam | KR | IVC Pragen GmbH | MT Promedt Consulting GmbH | St.Ingbert | DE | GenBody Influenza/COVID-19 Ag Multi | CVIFG010 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | http://www.ivc-pragen.com\ivd |
GenBody Inc. | Seobuk-gu, Cheonan-si, Chungcheongnam | KR | ASCANUS Pharma GmbH | MT Promedt Consulting GmbH | St.Ingbert | DE | GenBody-COVID-19 Ag | COVAG025 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | http://www.ascanus.de/4_1_de.html |
GenBody Inc. | Seobuk-gu, Cheonan-si, Chungcheongnam | KR | ASCANUS Pharma GmbH | MT Promedt Consulting GmbH | St.Ingbert | DE | GenBody Influenza/COVID-19 Ag Multi | CVIFG010 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | http://www.ascanus.de/4_1_de.html |
Green Cross Medical Science Corp. | Geumwang-eup, Eumseong-gun | KR | N/A | MT Promedt Consulting GmbH | St. Ingbert | DE | GENEDIA W COVID-19 Ag | 643G | 87,25 | 79,2 - 93,0 | 100 | 97,2 - 100 | https://drive.google.com/file/d/1eZZEHoLs8S9-UutvAJ3LmWI1o_dk8eFl/view?usp=sharing |
Guangdong Wesail Biotech Co., Ltd. | Dongguan, Guangdong | CN | Bio-Gram Diagnostics GmbH | Lotus NL B.V | Gravenhagen | NL | Covid-19 AG Test Kit | BE0040 | 82,5 | 68,05 - 91,25 | 98 | 96,36 - 98,91 | https://bio-gram.de/wp-content/uploads/2020/10/Packungsbeilage-COVID-19-Ag-Test-Kit.pdf |
Günter Keul GmbH | Steinfurt | DE | Keul-o-test® COVID-19 Antigen-Schnelltestkassette | KGST230 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - >99,9 | https://keul.de/wp-content/uploads/2020/10/KGST231_COVID19_Antigen_Anleitung_Ger_1020.pdf | ||||
Günter Keul GmbH | Steinfurt | DE | Keul-o-test® COVID-19 und Influenza A+B Antigen Combotest | KGST230 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | https://keul.de/wp-content/uploads/2020/10/KGST230_COVID19_Flu_Antigen-Combo_Anleitung_Ger_0920.pdf | ||||
Hangzhou AllTest Biotech Co, Ltd. | Hangzhou | CN | TREKSTOR GmbH | Lotus NL B.V. | The Hague | NL | blnk COVID-19 and Influenza A+B Antigen Combo Rapid Test | 30801 | 90,4 | 79 - 96,8 | 99,5 | 97,2 - 99,9 | https://www.blnk-healthcare.com/ifu/GA_30801_Antigentest_Kombi_EN-IT-DE-201015.pdf |
Hangzhou AllTest Biotech Co, Ltd. | Hangzhou | CN | TREKSTOR GmbH | Lotus NL B.V. | The Hague | NL | blnk COVID-19 Antigen Rapid Test | 30800 | 90,4 | 79 - 96,8 | 99,5 | 97,2 - 99,9 | https://www.blnk-healthcare.com/ifu/GA_30800_Antigentest_EN-IT-DE-201015.pdf |
Hangzhou AllTest Biotech Co., Ltd | Hangzhou | CN | Axon Lab AG | Lotus NL B.V. | The Hague | NL | COVID-19 Antigen Rapid Test | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | www.axonlab.de | |
Hangzhou AllTest Biotech Co., Ltd | Hangzhou | CN | PHARMADOC GmbH | Lotus NL B.V. | Den Haag | NL | COVID-19 und Influenza A+B Antigen Combo Schnelltest | 146288202 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | |
Hangzhou AllTest Biotech Co., Ltd | Hangzhou | CN | Axon Lab AG | Lotus NL B.V. | The Hague | NL | COVID-19 Antigen + Flu A/B Rapid Combo Test | ICIC-525 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | www.axonlab.de |
Hangzhou AllTest Biotech Co. Ltd. | Hangzhou | CN | Preventis GmbH | Lotus B.V. | Verd, The Hague | NL | Covid-19 Antigen Rapid Test | ICOV-502 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | |
Hangzhou AllTest Biotech Co. Ltd. | Hangzhou | CN | Preventis GmbH | Lotus B.V. | Verd, The Hague | NL | Covid-19 and Influenza A+B Antigen Rapid Test | ICOV-525 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | |
Hangzhou Clongene Biotech Co., Ltd. | Hangzhou | CN | Shanghai International Holding Corp.GmbH (Europe) | Hamburg | DE | COVID-19 Antigen Rapid Test | 98,5 | 91,8 - 99,7 | 100 | 98,2 - 100 | http://en.clongene.com/uploads/20201026/84b3080010c296f2c6259666c2b80745.pdf | ||
Hangzhou Laihe Biotech Co.,Ltd. | Hangzhou , Zhejiang Province | CN | Lissner Qi GmbH | SUNGO Europe B.V. | Amsterdam | NL | Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | 303035 | 95,07 | 91,13 - 97,61 | 99,74 | 98,55 - 99,99 | http://www.lissner-qi.de/aL628/w83720542d/Beipackzettel_DE.pdf |
Hangzhou Lysun Biotechnology Co., Ltd | Hangzhou | CN | Winlong GmbH | Lotus NL B.V | The Hague | NL | COVID-19 antigen Rapid Test Device (Colloidal Gold) | 91,67 | 84,67 - 98,67 | 100 | 99,8 - 100 | https://winlong.eu/wp-content/uploads/2020/10/Intruction-of-use-Lysun-2020-10.22.pdf | |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | fameditec GmbH | Luxus Lebenswelt GmbH | Willich | DE | CORA CHECK-19 | 90,32 | 75,51 - 92,77 | 99,99 | 97,73 - 100 | http://www.fameditec.de/cora-check-19-gebrauchsanweisung-25 | |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | PHARMADOC GmbH | Luxus Lebenswelt GmbH | Willich | DE | Realy SARS-CoV-2 Antigen Schnelltest | RT-K511416D | 96,17 | 92,51 - 98,17 | 99,99 | 98,98 - 100 | http://imaco.info/download/realy_codiv_beipack.pdf |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | TREKSTOR GmbH | Luxus Lebenswelt GmbH | Willich | DE | blnk Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) | 30802 | 96,17 | 92,51 - 98,17 | 99,9 | 98,48 - 100 | https://www.blnk-healthcare.com/ifu/GA_30802_Antigentest_EN-IT-DE.pdf |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | Dropshippers Germany, Ingo Grebe | Luxus Lebenswelt GmbH | Willich | DE | Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) | K511416D | 90,32 | 75,51 - 92,77 | 99,9 | 97,73 - 100 | https://dropshippers-germany.de/wp-content/REALY_TECH_-_SARS-Cov-2_Antigen_Rapid_Test_-_Gebrauchsanweisung_-_v1607_-_Dropshippers_Germany.pdf |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | Winlong GmbH | Luxus Lebenswelt GmbH | Willich | DE | Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) | K511416D | 90,32 | 75,51 - 92,77 | 99,9 | 97,73 - 100 | https://winlong.eu/wp-content/uploads/2020/10/Gebrauchsanweisung-Realy-Tech-Novel-Coronavirus-SARS-Cov-2-Antigen-Rapid-Test-Cassette-swab-25-test-ver-1.8-Winlong_DE.pdf |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | Deutsche HansaGT GmbH | Luxus Lebenswelt GmbH | Willich | DE | Realy Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test | 90,32 | 75,51 - 92,77 | 99,9 | 97,73 - 100 | https://cdn.website-editor.net/0b7a57acfd0e45f9b8a3f3bed5863f21/files/uploaded/Gebrauchsanweisung_Novel%2520Coronavirus%2520%2528SARS-Cov-2%2529%2520Antigen%2520Rapid%2520Test%2520Cassette%2520%2528swab%2529%252025%2520test%2520ver%25201.603.pdf | |
Healgen Scientific Limited Liability Company | Houston | US | Siemens Healthcare GmbH | Shanghai International Holding Corp. GmbH (Europe) | Hamburg | DE | Clinitest Rapid COVID-19 Antigentest - Coronavirus Ag Rapid Test Cassette (Swab) | 11555845 | 96,72 | 88,65 - 99,60 | 99,22 | 97,21 - 99,91 | https://www.siemens-healthineers.com/de/point-of-care-testing/covid-19-testing/covid-19-tests/clinitest-covid-19-antigen-test |
Healgen Scientific Limited Liability Company | Houston | US | TriPart Logistic GmbH | Shanghai International Holding Corp. GmbH (Europe) | Hamburg | DE | Coronavirus Ag Rapid Test Cassette (Swab) | GCCOV-502a | 96,72 | 88,65 - 99,60 | 99,22 | 97,21 - 99,91 | https://tripart-logistic.eu/transfer/Manual_v1.pdf |
Healgen Scientific Limites Liability Company | Huston | US | A. Menarini Diagnostics | DE | Coronavirus Ag Rapid Test Cassette (Swab) | GCOV-502-a (Menarinicode 51967) | 96,3 | 87,25 - 99,55 | 99,06 | 96,63 - 99,89 | |||
JOYSBIO (Tianjin) Biotechnology CO., LTD. | Tianjin | CN | Lotus NL B.V. | The Hague | NL | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) / Test Kit für neuartiges Coronavirus-Antigen (kolloidale Gold-Methode) | COV-AG-20 / G10313 | 88,89 | 75,9 - 96,3 | 99,05 | 94,8 - 100,0 | https://en.joysbio.com/wp-content/uploads/2020/10/JOYSBIO-SARS-COV-2-Antigen-Rapid-Test-Kit-IFU-German.pdf | |
LumiraDx UK Ltd. | Alloa, Stirling | UK | LumiraDx GmbH | LumiraDx AB | Solna | SE | LumiraDx SARS-CoV-2 Ag Test | L003000101048 | 97,5 | 87,1 - 99,6 | 97,7 | 94,7 - 99,0 | https://www.lumiradx.com/assets/pdfs/covid-19-antigen-test/sars-cov-2-ag-test-strip-product-insert-german.pdf |
MEDsan GmbH | Hamburg | DE | MEDsan® SARS-CoV-2 Antigen Rapid Test | T00023 (Single box) / T00019 (25er Packung) | 92,5 | 86,4 - 96,0 | 99,8 | 98,9 - 100 | https://www.medsan.eu/en/medsan-sars-cov-2-antigen-rapid-test-eu-version/ | ||||
MEDsan GmbH | Hamburg | DE | MEDsan® Multiplex (SC2 & Flu A/B) Rapid Test | T00032 (Single box) / T00033 (25er Packung) | 92,5 | 86,4 - 96,0 | 99,8 | 98,9 - 100 | https://www.medsan.eu/en/medsan-multiplex-sc2-flu-a-b-rapid-test-eu-version/ | ||||
MEXACARE GmbH | Heidelberg | DE | MEXACARE GmbH | COVID-19 Antigen (Nasen- Rachenabstrich) | 3011030 | 93,5 | 82,4 - 97,1 | 99,5 | 94,2 - 99,7 | https://www.mexacare.com/index.php?id=725 | |||
MEXACARE GmbH | Heidelberg | DE | MEXACARE GmbH | COVID-19 & Influenza A+B Antigen Combo Schnelltest | 30110333 | 93,75 | 86,14 - 97,3 | 98,3 | 91,1 - 99,9 | https://www.mexacare.com/index.php?id=725 | |||
möLab GmbH | Langenfeld | DE | mö-screen Corona Antigen Test | 230005 | 96,72 | 88,65 - 99,60 | 99,22 | 97,21 - 99,91 | https://www.moelab.de/covid-19.html | ||||
nal von minden GmbH | Moers | DE | NADAL COVID-19 Ag Test | 243103-N20 | 97,6 | 93,1 - 99,2 | 99,9 | 97,7 - 100 | https://www.nal-vonminden.com/pdf/243103N-20_MPI%20A1_A2_COVID-19%20AgTest_20201012.pdf | ||||
nal von minden GmbH | Moers | DE | NADAL COVID-19 Ag+Influenza A/B Test | 243203-N20 | 97,6 | 93,1 - 99,2 | 99,9 | 97,7 - 100 | http://www.nal-vonminden.com/pdf/243203N-20_MPI%20A1_A2_COVID-19%20Ag%20Inf%20A%20B%20Test_20201012.pdf | ||||
nal von Minden GmbH | Moers | DE | Axon Lab AG | NADAL® COVID-19 Ag Test | 243103N-20 | 97,6 | 93,1 - 99,2 | 99,9 | 97,7 - 100 | https://www.nadal-test.com/de | |||
NanoEntek Inc | Guro-gu,Seoul | KR | MS Med-Tech Supplies GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | FREND COVID-19 Ag | FRCOG020 | 94,12 | 78,94 - 98,97 | 100 | 93,93 - 100 | https://med-supplies.de/FREND_COVID-19_Ag_PI_DE.pdf |
PCL, Inc. | Geumcheon-gu, Seoul | KR | Datametrex AI Limited | DE | PCL COVID19 Ag Rapid FIA | 88,71 | 78,1 - 95,34 | 98,61 | 92,50 - 99,96 | ||||
Precision Biosensor | Yuseong-gu, Daejeon | KR | Axon Lab AG | MDI Europa GmbH | Langenhagen | DE | Exdia COVID-19 Ag | PR-FC13 | 93,88 | 83,5 - 97,9 | 98 | 89,5 - 99,6 | https://drive.google.com/file/d/1He3GRrq01zySFkpmysTWn_Q3lob9AiRX/view?usp=drivesdk |
Quidel Corporation | San Diego, CA | US | Quidel Germany GmbH | MDSS GmbH | Hannover | DE | Sofia SARS Antigen FIA | 20378 | 96,7 | 83,3 - 99,4 | 100 | 97,9 - 100 | https://www.quidel.com/sites/default/files/product/documents/EF1451901DE00_08_20_Sofia_SARS_Antigen_XUS_Pkg_Insert.pdf |
R-Biopharm AG | Darmstadt | DE | RIDA®QUICK SARS-CoV-2 Antigen | N6803 | 95 | 84 - 99 | 100 | 66 - 100 | https://clinical.r-biopharm.com/wp-content/uploads/sites/3/2020/10/n6803_ridaquick-sars-cov-2_antigen_2020-10-15_de.pdf | ||||
Salofa Oy | Salu | FI | Promeditech GmbH | SIENNA COVID-19 Antigen Rapid Test Cassette | 102241 | 95 | 83,1 - 99,4 | 99,2 | 97,6 - 99,8 | https://shop.promeditech.de/documents/Sienna_Ag_102241_GBA_D-19102020.pdf | |||
ScheBo Biotech AG | Gießen | DE | ScheBo Biotech AG | ScheBo SARS-CoV-2 Quick ANTIGEN | 34 | 96,77 | 88,83 - 99,61 | 98,94 | 96,21 - 99,87 | https://www.schebo.de/wp-content/uploads/2020/10/ScheBo-SARS-CoV-2_QUICK_ANTIGEN_Gebrauchsanweisung_DE_GB.pdf | |||
SD Biosensor | Heungdeok-gu, Cheongju-si, Chungcheongbuk-do | KR | bestbion dx GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | Standard F COVID-19 Ag FIA Reagenzienkit | 31B10008 | 94 | 80,32 - 99,28 | 97 | 83,3 - 99,92 | https://bestbion.com/wp-content/uploads/2020/09/bestbiondx_GA_COVID19_FIA_20200916.pdf |
SD Biosensor | Heungdeok-gu, Cheongju-si, Chungcheongbuk-do | KR | bestbion dx GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | Standard Q Covid-19 Ag Reagenzienkit | 31B20002 | 96,52 | 91,33 – 99,04 | 99,68 | 98,22 - 99,99 | https://bestbion.com/sars-cov-2_covid-19/ |
SD Biosensor Inc. | Yeongtong-gu, Suwon-si, Gyeonggi-do 16690 | KR | Roche Diagnostics GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | SARS-CoV-2 Rapid Antigen Test | 9327592190 | 96,52 | 91,33 - 99,04 | 99,68 | 98,22 - 99,99 | https://www.roche.de/res/content/11722/packungsbeilage_sars-cov-2_rapid_antigen_test.pdf |
Servoprax GmbH | Wesel | DE | Cleartest Corona-Antigen | C3 4800-10/-20/-50/-100 | 96,5 | 92,6 - 98,7 | 99,5 | 97,2 - 99,9 | https://data.servoprax.de/ftp/1-C3_4800-5ff-222-2-0002-2010.pdf | ||||
Shenzhen Microprofit Biotech Co., Ltd | Shenzhen | CN | SVAN International Import & Export Co. Ltd. | CMC Medical Devices & Drugs SL | Malaga | ES | Fluorocare SARS-CoV-2 Spike Protein Test kit - Colloidal Gold | AG01CGS | 88,24 | 76,13 - 95,56 | 100 | 98,78 - 100 | https://3ps-medical-care.de/ |
Shenzhen Microprofit Biotech Co., Ltd | Shenzhen | CN | SVAN International Import & Export Co. Ltd. | CMC Medical Devices & Drugs SL | Malaga | ES | Fluorocare SARS-CoV-2 Spike Protein Test kit - Immunofluorescence type | AG01IFS | 92,16 | 81,12 - 97,82 | 100 | 98,78 - 100 | |
Sugentech, INC. | Cheongju | KR | DiaSys Deutschland Vertriebs-GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | SGTi-flex COVID-19 Ag | CAGT025E1 | 91,57 | 83,60 - 95,85 | 99 | 94,55 - 99,82 | https://www.diasys-deutschland.de/produkte/schnelldiagnostika/ |
TaiDoc Technology Corporation | New Taipei City | TW | EC-REP MedNet GmbH | Muenster | DE | VTRUST TD-4531 'COVID-19 Antigen Rapid Test' | 85,7 | 65,4 - 95,0 | 98,6 | 92,4 - 100 | https://www.dropbox.com/sh/yeycbehlb4tnily/AAC6Oq8o0_KY-mSXnX1dSTTga?dl=0 | ||
Unioninvest Ltd. | Istanbul | TR | Science&Care Vertriebs GmbH | Science&Care Vertriebs GmbH | Laudenbach | DE | UNIBIOSCIENCE SARS-COV-19-2 AG SCHNELLTEST | 97,44 | 95,47 - 98,72 | 99,3 | 98,68 - 99,68 | http://bit.ly/Unibioscience_DE_IFU | |
VivaChek Biotech (Hangzhou) Co., Ltd. | Hangzhou | CN | MSP bodmann GmbH | Lotus NL B.V. | The Hague | NL | VivaDiagTM SARS-CoV-2 Ag Schnelltest | 59 | 90,9 | 81,55 - 95,77 | 100 | 99,12 - 100 | https://mspbodmann.sharepoint.com/:b:/s/MSPDesign/ETfTSkULWZBBh-qqtXE6N-kBPy6PFxbsgQUJijoKjoKW2Q?e=Kdtmc9 |
VivaChek Biotech (Hangzhou) Co., Ltd. | Hangzhou | CN | PHARMADOC GmbH | Lotus NL B.V. | Den Haag | NL | VivaDiagTM SARS-CoV-2 Ag Schnelltest | VCD05-01-011 | 90,9 | 81,55 - 95,77 | 100 | 99,12 - 100 | http://imaco.info/download/vivadiag_covid.pdf |
Xiamen Biotime Biotechnology Co., Ltd. | Fujan | CN | MEDICE Arzneimittel Pütter GmbH & Co. KG | Logcon East GmbH | Wien | AT | Medicovid-AG SARS-CoV-2 Antigen Schnelltest | 96 | 88,75 - 100 | 100 | 98,34 - 100,0 | https://medice.com/api/de-de/service/downloads/403000002001-gi-sars-cov-2-antigen-schnellt-medicovid.pdf | |
Xiamen Biotime Biotechnology Co Ltd. | Xiamen | CN | Logcon East GmbH | Wien | AT | Biotime SARS-CoV-2 Antigen Rapid Qualitative Test | 96 | 88,75 - 99,17 | 100 | 98,34 - 100,00 | https://alpshealth.org/downloads/regulatory_materials/antigen/germany/SARS-CoV-2%20Antigen%20Test%20Gebrauchsanweisung_final-end.pdf | ||
Zhejiang Orient Gene Biotech Co. Ltd | Huzhou, Zhejiang | CN | A. Menarini Diagnostics | Shanghai International Holding Corp GmbH(Europe) | Hamburg | DE | Coronavirus Ag Rapid Test Cassette (Swab) | GCOV-502-a (Menarinicode 51967) | 96,3 | 87,25 - 99,55 | 99,06 | 96,63 - 99,89 | |
Zhejiang Orient Gene Biotech Co.,Ltd | Huzhou | CN | Alphagen GmbH | Shanghai International Holding Corp.GmbH (Europe) | Hamburg | DE | Covid-19 Rapid Ag Test Cassette | GCCOV-502a | 96,72 | 88,65 - 99,6 | 99,22 | 97,21 - 99,91 | https://www.alphascience.de/downloads/gebrauchsanweisung_covid-19_antigen_schnelltes.pdf |
Sortiert nach "Sensitivität"
Hersteller Name | Hersteller Stadt | Hersteller Land | Deutsche/r Vertreiber | EU Bevollmächtigter Name | EU Bevollmächtigter Stadt | EU Bevollmächtigter Land | Handelsname des Tests | Artikelnummer | Sensitivität % | 95%iges Vertrauensintervall (Sensitivität) | Spezifität % | 95%iges Vertrauensintervall (Spezifität) | Gebrauchsanweisung |
Hangzhou Clongene Biotech Co., Ltd. | Hangzhou | CN | Shanghai International Holding Corp.GmbH (Europe) | Hamburg | DE | COVID-19 Antigen Rapid Test | 98,5 | 91,8 - 99,7 | 100 | 98,2 - 100 | http://en.clongene.com/uploads/20201026/84b3080010c296f2c6259666c2b80745.pdf | ||
nal von minden GmbH | Moers | DE | NADAL COVID-19 Ag Test | 243103-N20 | 97,6 | 93,1 - 99,2 | 99,9 | 97,7 - 100 | https://www.nal-vonminden.com/pdf/243103N-20_MPI%20A1_A2_COVID-19%20AgTest_20201012.pdf | ||||
nal von minden GmbH | Moers | DE | NADAL COVID-19 Ag+Influenza A/B Test | 243203-N20 | 97,6 | 93,1 - 99,2 | 99,9 | 97,7 - 100 | http://www.nal-vonminden.com/pdf/243203N-20_MPI%20A1_A2_COVID-19%20Ag%20Inf%20A%20B%20Test_20201012.pdf | ||||
nal von Minden GmbH | Moers | DE | Axon Lab AG | NADAL® COVID-19 Ag Test | 243103N-20 | 97,6 | 93,1 - 99,2 | 99,9 | 97,7 - 100 | https://www.nadal-test.com/de | |||
LumiraDx UK Ltd. | Alloa, Stirling | UK | LumiraDx GmbH | LumiraDx AB | Solna | SE | LumiraDx SARS-CoV-2 Ag Test | L003000101048 | 97,5 | 87,1 - 99,6 | 97,7 | 94,7 - 99,0 | https://www.lumiradx.com/assets/pdfs/covid-19-antigen-test/sars-cov-2-ag-test-strip-product-insert-german.pdf |
Unioninvest Ltd. | Istanbul | TR | Science&Care Vertriebs GmbH | Science&Care Vertriebs GmbH | Laudenbach | DE | UNIBIOSCIENCE SARS-COV-19-2 AG SCHNELLTEST | 97,44 | 95,47 - 98,72 | 99,3 | 98,68 - 99,68 | http://bit.ly/Unibioscience_DE_IFU | |
AMEDA Labordiagnostik GmbH | Graz | AT | DIM LabService GmbH & Co. KG | AMP Rapid Test SARS-CoV-2 Ag | RT2951 / RT 2952 | 97,3 | 90,0 - 99,8 | 100 | 96,6 - 100 | ||||
Beijing Hotgen Biotech Co.,Ltd | Peking | CN | Dr. Grob Healthcare | MedNet GmbH | Münster | DE | Coronavirus 2019-nCoV Antigen Test | ANTIGEN97 | 97,1 | 93,80 - 98,93 | 99,76 | 98,65 - 99,99 | http://www.dr-grob.com/antigen97 |
Biohit Healthcare (Hefei) Co., Ltd. | Hefei | CN | ScheBo Biotech AG | ScheBo Biotech AG | Gießen | DE | SARS-CoV-2 Antigen Rapid Test Kit | 34 | 96,77 | 88,83 - 99,61 | 98,94 | 96,21 - 99,87 | https://www.schebo.de/produkte/artikel-34-testanleitung/ |
ScheBo Biotech AG | Gießen | DE | ScheBo Biotech AG | ScheBo SARS-CoV-2 Quick ANTIGEN | 34 | 96,77 | 88,83 - 99,61 | 98,94 | 96,21 - 99,87 | https://www.schebo.de/wp-content/uploads/2020/10/ScheBo-SARS-CoV-2_QUICK_ANTIGEN_Gebrauchsanweisung_DE_GB.pdf | |||
Healgen Scientific Limited Liability Company | Houston | US | Siemens Healthcare GmbH | Shanghai International Holding Corp. GmbH (Europe) | Hamburg | DE | Clinitest Rapid COVID-19 Antigentest - Coronavirus Ag Rapid Test Cassette (Swab) | 11555845 | 96,72 | 88,65 - 99,60 | 99,22 | 97,21 - 99,91 | https://www.siemens-healthineers.com/de/point-of-care-testing/covid-19-testing/covid-19-tests/clinitest-covid-19-antigen-test |
Healgen Scientific Limited Liability Company | Houston | US | TriPart Logistic GmbH | Shanghai International Holding Corp. GmbH (Europe) | Hamburg | DE | Coronavirus Ag Rapid Test Cassette (Swab) | GCCOV-502a | 96,72 | 88,65 - 99,60 | 99,22 | 97,21 - 99,91 | https://tripart-logistic.eu/transfer/Manual_v1.pdf |
möLab GmbH | Langenfeld | DE | mö-screen Corona Antigen Test | 230005 | 96,72 | 88,65 - 99,60 | 99,22 | 97,21 - 99,91 | https://www.moelab.de/covid-19.html | ||||
Zhejiang Orient Gene Biotech Co.,Ltd | Huzhou | CN | Alphagen GmbH | Shanghai International Holding Corp.GmbH (Europe) | Hamburg | DE | Covid-19 Rapid Ag Test Cassette | GCCOV-502a | 96,72 | 88,65 - 99,6 | 99,22 | 97,21 - 99,91 | https://www.alphascience.de/downloads/gebrauchsanweisung_covid-19_antigen_schnelltes.pdf |
Quidel Corporation | San Diego, CA | US | Quidel Germany GmbH | MDSS GmbH | Hannover | DE | Sofia SARS Antigen FIA | 20378 | 96,7 | 83,3 - 99,4 | 100 | 97,9 - 100 | https://www.quidel.com/sites/default/files/product/documents/EF1451901DE00_08_20_Sofia_SARS_Antigen_XUS_Pkg_Insert.pdf |
Beijing Hotgen Biotech Co., Ltd | Beijing | CN | fameditec GmbH | MedNet GmbH | Münster | DE | CORA CHECK-19 | 4,27E+12 | 96,62 | 99,76 | https://www.fameditec.de/cora-check-19-gebrauchsanweisung | ||
SD Biosensor | Heungdeok-gu, Cheongju-si, Chungcheongbuk-do | KR | bestbion dx GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | Standard Q Covid-19 Ag Reagenzienkit | 31B20002 | 96,52 | 91,33 – 99,04 | 99,68 | 98,22 - 99,99 | https://bestbion.com/sars-cov-2_covid-19/ |
SD Biosensor Inc. | Yeongtong-gu, Suwon-si, Gyeonggi-do 16690 | KR | Roche Diagnostics GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | SARS-CoV-2 Rapid Antigen Test | 9327592190 | 96,52 | 91,33 - 99,04 | 99,68 | 98,22 - 99,99 | https://www.roche.de/res/content/11722/packungsbeilage_sars-cov-2_rapid_antigen_test.pdf |
Beijing Beier Bioengineering Co., Ltd. | Beijing | CN | High Lux International Trading GmbH | MedNet EC-REP GmbH | Münster | DE | COVID-19 Antigen Rapid Test Kit | 96,5 | 93,7 - 99,3 | 99,7 | 99,0 - 100 | http://www.beierbio.com/en/uploadfile/2020-10-23/4976409d-2b1c-4f47-8495-07d8e83b5a40.pdf | |
Devidia GmbH | Weimar | DE | DEDIATEST 2019-nCoV Antigen Rapid Test | 2.13.1.555 | 96,5 | 92,6 - 98,7 | 99,5 | 97,2 - 99,9 | https://www.testyounow.com/instructions | ||||
Servoprax GmbH | Wesel | DE | Cleartest Corona-Antigen | C3 4800-10/-20/-50/-100 | 96,5 | 92,6 - 98,7 | 99,5 | 97,2 - 99,9 | https://data.servoprax.de/ftp/1-C3_4800-5ff-222-2-0002-2010.pdf | ||||
Healgen Scientific Limites Liability Company | Huston | US | A. Menarini Diagnostics | DE | Coronavirus Ag Rapid Test Cassette (Swab) | GCOV-502-a (Menarinicode 51967) | 96,3 | 87,25 - 99,55 | 99,06 | 96,63 - 99,89 | |||
Zhejiang Orient Gene Biotech Co. Ltd | Huzhou, Zhejiang | CN | A. Menarini Diagnostics | Shanghai International Holding Corp GmbH(Europe) | Hamburg | DE | Coronavirus Ag Rapid Test Cassette (Swab) | GCOV-502-a (Menarinicode 51967) | 96,3 | 87,25 - 99,55 | 99,06 | 96,63 - 99,89 | |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | PHARMADOC GmbH | Luxus Lebenswelt GmbH | Willich | DE | Realy SARS-CoV-2 Antigen Schnelltest | RT-K511416D | 96,17 | 92,51 - 98,17 | 99,99 | 98,98 - 100 | http://imaco.info/download/realy_codiv_beipack.pdf |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | TREKSTOR GmbH | Luxus Lebenswelt GmbH | Willich | DE | blnk Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) | 30802 | 96,17 | 92,51 - 98,17 | 99,9 | 98,48 - 100 | https://www.blnk-healthcare.com/ifu/GA_30802_Antigentest_EN-IT-DE.pdf |
Biosynex Swiss SA | Freiburg | CH | Aidian Germany GmbH | FR | BIOSYNEX COVID-19 Ag BSS | SW40006 | 96 | 93,6 - 98,4 | 100 | 100 - 100 | https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Biosynex/IFU_SW40006_DE_V03202008R03.pdf | ||
Xiamen Biotime Biotechnology Co., Ltd. | Fujan | CN | MEDICE Arzneimittel Pütter GmbH & Co. KG | Logcon East GmbH | Wien | AT | Medicovid-AG SARS-CoV-2 Antigen Schnelltest | 96 | 88,75 - 100 | 100 | 98,34 - 100,0 | https://medice.com/api/de-de/service/downloads/403000002001-gi-sars-cov-2-antigen-schnellt-medicovid.pdf | |
Xiamen Biotime Biotechnology Co Ltd. | Xiamen | CN | Logcon East GmbH | Wien | AT | Biotime SARS-CoV-2 Antigen Rapid Qualitative Test | 96 | 88,75 - 99,17 | 100 | 98,34 - 100,00 | https://alpshealth.org/downloads/regulatory_materials/antigen/germany/SARS-CoV-2%20Antigen%20Test%20Gebrauchsanweisung_final-end.pdf | ||
Hangzhou Laihe Biotech Co.,Ltd. | Hangzhou , Zhejiang Province | CN | Lissner Qi GmbH | SUNGO Europe B.V. | Amsterdam | NL | Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | 303035 | 95,07 | 91,13 - 97,61 | 99,74 | 98,55 - 99,99 | http://www.lissner-qi.de/aL628/w83720542d/Beipackzettel_DE.pdf |
R-Biopharm AG | Darmstadt | DE | RIDA®QUICK SARS-CoV-2 Antigen | N6803 | 95 | 84 - 99 | 100 | 66 - 100 | https://clinical.r-biopharm.com/wp-content/uploads/sites/3/2020/10/n6803_ridaquick-sars-cov-2_antigen_2020-10-15_de.pdf | ||||
Salofa Oy | Salu | FI | Promeditech GmbH | SIENNA COVID-19 Antigen Rapid Test Cassette | 102241 | 95 | 83,1 - 99,4 | 99,2 | 97,6 - 99,8 | https://shop.promeditech.de/documents/Sienna_Ag_102241_GBA_D-19102020.pdf | |||
BTNX INC. | Ontario L3R 4G7 | CA | NanoRepro AG | MDSS GmbH | Hannover | DE | Rapid Response COVID-19 Antigen Rapid Test Device | COV-19C25 | 94,55 | 83,93 - 98,58 | 100 | 97,1 - 100 | https://www.nanorepro.com/media/nanorepro-covid-19-antigen-packungsbeilage.pdf |
Azure Biotech,Inc | Houston,Texas | US | NanoRepro AG | Lotus NL B.V. | The Hague | NL | Dia Sure COVID-19 Antigen Rapid Test Device | 94,3 | 84,6 - 98,1 | 99,1 | 98,4 - 99,5 | https://www.nanorepro.com/media/nanorepro-covid-19-antigen-ab-packungsbeilage.pdf | |
NanoEntek Inc | Guro-gu,Seoul | KR | MS Med-Tech Supplies GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | FREND COVID-19 Ag | FRCOG020 | 94,12 | 78,94 - 98,97 | 100 | 93,93 - 100 | https://med-supplies.de/FREND_COVID-19_Ag_PI_DE.pdf |
SD Biosensor | Heungdeok-gu, Cheongju-si, Chungcheongbuk-do | KR | bestbion dx GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | Standard F COVID-19 Ag FIA Reagenzienkit | 31B10008 | 94 | 80,32 - 99,28 | 97 | 83,3 - 99,92 | https://bestbion.com/wp-content/uploads/2020/09/bestbiondx_GA_COVID19_FIA_20200916.pdf |
Precision Biosensor | Yuseong-gu, Daejeon | KR | Axon Lab AG | MDI Europa GmbH | Langenhagen | DE | Exdia COVID-19 Ag | PR-FC13 | 93,88 | 83,5 - 97,9 | 98 | 89,5 - 99,6 | https://drive.google.com/file/d/1He3GRrq01zySFkpmysTWn_Q3lob9AiRX/view?usp=drivesdk |
MEXACARE GmbH | Heidelberg | DE | MEXACARE GmbH | COVID-19 & Influenza A+B Antigen Combo Schnelltest | 30110333 | 93,75 | 86,14 - 97,3 | 98,3 | 91,1 - 99,9 | https://www.mexacare.com/index.php?id=725 | |||
MEXACARE GmbH | Heidelberg | DE | MEXACARE GmbH | COVID-19 Antigen (Nasen- Rachenabstrich) | 3011030 | 93,5 | 82,4 - 97,1 | 99,5 | 94,2 - 99,7 | https://www.mexacare.com/index.php?id=725 | |||
CerTest Biotec S.L. | Zaragoza | ES | bestbion dx GmbH | DE | SARS-CoV-2 + Flu A + B + RSV Quad Kassettenschnelltest inkl. Tupfer + pos. Kontrolle | 03B11044 | 92,9 | 76,5 – 99,1 | 99,6 | 97,6 – 100,0 | https://www.certest.es/wp-content/uploads/2020/09/QUAD_IU-SV86-v.01.pdf | ||
CerTest Biotec S.L. | Zaragoza | ES | bestbion dx GmbH | DE | SARS-CoV-2 Kassettenschnelltest inkl. pos. Kontrolle | 03B11041 | 92,9 | 76,5 – 99,1 | 99,6 | 97,6 – 100,0 | https://www.certest.es/wp-content/uploads/2020/09/Web_SARS-CoV-2_SINGLE_IU-SC8-v.02.1.pdf | ||
MEDsan GmbH | Hamburg | DE | MEDsan® SARS-CoV-2 Antigen Rapid Test | T00023 (Single box) / T00019 (25er Packung) | 92,5 | 86,4 - 96,0 | 99,8 | 98,9 - 100 | https://www.medsan.eu/en/medsan-sars-cov-2-antigen-rapid-test-eu-version/ | ||||
MEDsan GmbH | Hamburg | DE | MEDsan® Multiplex (SC2 & Flu A/B) Rapid Test | T00032 (Single box) / T00033 (25er Packung) | 92,5 | 86,4 - 96,0 | 99,8 | 98,9 - 100 | https://www.medsan.eu/en/medsan-multiplex-sc2-flu-a-b-rapid-test-eu-version/ | ||||
Shenzhen Microprofit Biotech Co., Ltd | Shenzhen | CN | SVAN International Import & Export Co. Ltd. | CMC Medical Devices & Drugs SL | Malaga | ES | Fluorocare SARS-CoV-2 Spike Protein Test kit - Immunofluorescence type | AG01IFS | 92,16 | 81,12 - 97,82 | 100 | 98,78 - 100 | |
Beijing Lepu Medical Technology Co., Ltd | Beijing | CN | Frohvogel Medizinprodukte UG | Lepu Medical (Europe) Cooperatief U.A. | Heerenveen | NL | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | N/A | 92 | 83,63 - 96,28 | 99,26 | 95,92 - 99,87 | http://www.frohvogel.de/ |
Beijing Lepu Medical Technology Co., Ltd | Beijing | CN | Deutsche HansaGT GmbH | Lepu Medical (Europe) Cooperatief U.A | Heerenveen | NL | Lepu SARS-CoV-2 Antigen Rapid Test Kit | 92 | 83,63 - 96,28 | 99,26 | 95,92 - 99,87 | https://cdn.website-editor.net/0b7a57acfd0e45f9b8a3f3bed5863f21/files/uploaded/anleitung%2520Lepu.pdf | |
Beijing Lepu Medical Technology Co., Ltd | Beijing | CN | Icon Medlab GmbH | Lepu Medical (Europe) Cooperatief U.A. | Heerenveen | NL | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal GoldImmunochromatography) | 92 | 83,63 - 96,28 | 99,26 | 95,92 - 99,87 | https://www.iconmedlab.com/service | |
Beijing Lepu Medical Technology Co., Ltd | Beijing | CN | Temiz AVZ GmbH | Lepu Medical (Europe) Cooperatief U.A. | Heerenveen | NL | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | 92 | 83,63 - 96,28 | 99,26 | 95,92 - 99,87 | https://www.antiviruszentrum.de/downloads/gebrauchsanweisung | |
Fujirebio Inc. | Shinjuku-ku,Tokyo | JP | Fujirebio Germany GmbH | Fujirebio Europe N.V. | Gent | BE | Lumipulse G SARS-CoV-2 Ag | 260340 | 91,7 | 74,2 - 97,7 | 97,3 | 94,8 - 98,6 | http://www.e-labeling.eu/FRI |
Hangzhou Lysun Biotechnology Co., Ltd | Hangzhou | CN | Winlong GmbH | Lotus NL B.V | The Hague | NL | COVID-19 antigen Rapid Test Device (Colloidal Gold) | 91,67 | 84,67 - 98,67 | 100 | 99,8 - 100 | https://winlong.eu/wp-content/uploads/2020/10/Intruction-of-use-Lysun-2020-10.22.pdf | |
Sugentech, INC. | Cheongju | KR | DiaSys Deutschland Vertriebs-GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | SGTi-flex COVID-19 Ag | CAGT025E1 | 91,57 | 83,60 - 95,85 | 99 | 94,55 - 99,82 | https://www.diasys-deutschland.de/produkte/schnelldiagnostika/ |
Abbott Rapid Diagnostics Jena GmbH | Jena | DE | Abbott Rapid Diagnostics Germany GmbH | Panbio™ COVID-19 Ag Rapid Test Device | 41FK10 | 91,4 | 85,5 - 95,5 | 99,8 | 98,8 - 100 | https://ensur.invmed.com/ensur/contentAction.aspx?key=ensur.547995.S2R4E4A3.20201014.11230.4318006 | |||
Edinburgh Genetics Limited | Penicuik | GB | Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit | 91,2 | 90 - 92,4 | 98,6 | 97,8 - 99,4 | https://www.eggenetics.com/wp-content/uploads/2020/10/Edinburgh-Genetics-ActivXpress-COVID-19-Antigen-Complete-Testing-Kit-German-v1.6.pdf | |||||
VivaChek Biotech (Hangzhou) Co., Ltd. | Hangzhou | CN | MSP bodmann GmbH | Lotus NL B.V. | The Hague | NL | VivaDiagTM SARS-CoV-2 Ag Schnelltest | 59 | 90,9 | 81,55 - 95,77 | 100 | 99,12 - 100 | https://mspbodmann.sharepoint.com/:b:/s/MSPDesign/ETfTSkULWZBBh-qqtXE6N-kBPy6PFxbsgQUJijoKjoKW2Q?e=Kdtmc9 |
VivaChek Biotech (Hangzhou) Co., Ltd. | Hangzhou | CN | PHARMADOC GmbH | Lotus NL B.V. | Den Haag | NL | VivaDiagTM SARS-CoV-2 Ag Schnelltest | VCD05-01-011 | 90,9 | 81,55 - 95,77 | 100 | 99,12 - 100 | http://imaco.info/download/vivadiag_covid.pdf |
Acro Biotech Inc. | Rancho Cucamonga | US | Aidian Germany GmbH | MedNet GmbH | Münster | DE | Acro COVID-19 and Influenza A+B Antigen Combo Rapid Test | ICIC-ACO525 | 90,4 | 79 - 96,8 | 99,5 | 97,2 - 99,9 | https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Acro/146300304_ICIC-525_ACRO_CE_EN_PI.pdf |
Acro Biotech Inc. | Rancho Cucamonga | US | Aidian Germany GmbH | MedNet GmbH | Münster | DE | Acro COVID-19 Antigen Rapid Test | INCP-ACO502 | 90,4 | 79 - 96,8 | 99,5 | 97,2 - 99,9 | https://www.aidian.eu/uploads/DE-Broschuren-und-Dokumente/ES-Products/Acro/146300204_ICOV-502_ACRO_CE_EN_PI.pdf |
Boditech Med Inc. | Chuncheon-si, Gang-won-do | KR | gurumB GmbH | Obelis s.a | Brussels | BE | ichroma™ COVI-19 Ag | 90,4 | 83,2 - 94,7 | 97,6 | 91,5 - 99,3 | https://www.gurumb.eu/ichroma-ii-covid-19-ag-de-gebrauchsanweisung | |
Günter Keul GmbH | Steinfurt | DE | Keul-o-test® COVID-19 Antigen-Schnelltestkassette | KGST230 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - >99,9 | https://keul.de/wp-content/uploads/2020/10/KGST231_COVID19_Antigen_Anleitung_Ger_1020.pdf | ||||
Günter Keul GmbH | Steinfurt | DE | Keul-o-test® COVID-19 und Influenza A+B Antigen Combotest | KGST230 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | https://keul.de/wp-content/uploads/2020/10/KGST230_COVID19_Flu_Antigen-Combo_Anleitung_Ger_0920.pdf | ||||
Hangzhou AllTest Biotech Co, Ltd. | Hangzhou | CN | TREKSTOR GmbH | Lotus NL B.V. | The Hague | NL | blnk COVID-19 and Influenza A+B Antigen Combo Rapid Test | 30801 | 90,4 | 79 - 96,8 | 99,5 | 97,2 - 99,9 | https://www.blnk-healthcare.com/ifu/GA_30801_Antigentest_Kombi_EN-IT-DE-201015.pdf |
Hangzhou AllTest Biotech Co, Ltd. | Hangzhou | CN | TREKSTOR GmbH | Lotus NL B.V. | The Hague | NL | blnk COVID-19 Antigen Rapid Test | 30800 | 90,4 | 79 - 96,8 | 99,5 | 97,2 - 99,9 | https://www.blnk-healthcare.com/ifu/GA_30800_Antigentest_EN-IT-DE-201015.pdf |
Hangzhou AllTest Biotech Co., Ltd | Hangzhou | CN | Axon Lab AG | Lotus NL B.V. | The Hague | NL | COVID-19 Antigen Rapid Test | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | www.axonlab.de | |
Hangzhou AllTest Biotech Co., Ltd | Hangzhou | CN | PHARMADOC GmbH | Lotus NL B.V. | Den Haag | NL | COVID-19 und Influenza A+B Antigen Combo Schnelltest | 146288202 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | |
Hangzhou AllTest Biotech Co., Ltd | Hangzhou | CN | Axon Lab AG | Lotus NL B.V. | The Hague | NL | COVID-19 Antigen + Flu A/B Rapid Combo Test | ICIC-525 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | www.axonlab.de |
Hangzhou AllTest Biotech Co. Ltd. | Hangzhou | CN | Preventis GmbH | Lotus B.V. | Verd, The Hague | NL | Covid-19 Antigen Rapid Test | ICOV-502 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | |
Hangzhou AllTest Biotech Co. Ltd. | Hangzhou | CN | Preventis GmbH | Lotus B.V. | Verd, The Hague | NL | Covid-19 and Influenza A+B Antigen Rapid Test | ICOV-525 | 90,4 | 79,0 - 96,8 | 99,5 | 97,2 - 99,9 | |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | fameditec GmbH | Luxus Lebenswelt GmbH | Willich | DE | CORA CHECK-19 | 90,32 | 75,51 - 92,77 | 99,99 | 97,73 - 100 | http://www.fameditec.de/cora-check-19-gebrauchsanweisung-25 | |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | Dropshippers Germany, Ingo Grebe | Luxus Lebenswelt GmbH | Willich | DE | Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) | K511416D | 90,32 | 75,51 - 92,77 | 99,9 | 97,73 - 100 | https://dropshippers-germany.de/wp-content/REALY_TECH_-_SARS-Cov-2_Antigen_Rapid_Test_-_Gebrauchsanweisung_-_v1607_-_Dropshippers_Germany.pdf |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | Winlong GmbH | Luxus Lebenswelt GmbH | Willich | DE | Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (Swab) | K511416D | 90,32 | 75,51 - 92,77 | 99,9 | 97,73 - 100 | https://winlong.eu/wp-content/uploads/2020/10/Gebrauchsanweisung-Realy-Tech-Novel-Coronavirus-SARS-Cov-2-Antigen-Rapid-Test-Cassette-swab-25-test-ver-1.8-Winlong_DE.pdf |
Hangzhou Realy Tech Co., Ltd | Hangzhou | CN | Deutsche HansaGT GmbH | Luxus Lebenswelt GmbH | Willich | DE | Realy Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test | 90,32 | 75,51 - 92,77 | 99,9 | 97,73 - 100 | https://cdn.website-editor.net/0b7a57acfd0e45f9b8a3f3bed5863f21/files/uploaded/Gebrauchsanweisung_Novel%2520Coronavirus%2520%2528SARS-Cov-2%2529%2520Antigen%2520Rapid%2520Test%2520Cassette%2520%2528swab%2529%252025%2520test%2520ver%25201.603.pdf | |
GenBody Inc. | Cheonan-si | KR | Meridian Bioscience Europe SRL | MT Promedt Consulting GmbH | Sankt ingbert | DE | GenBody COVID-19 Ag | Cat. No.: COVAG025 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | |
GenBody Inc. | Chungcheongnam-do | KR | Preventor µTBC GmbH | Preventor µTBC GmbH | Pfungstadt | DE | GenBody Influenza/COVID-19 Multi Ag Schnelltest | PRVCVIFG010-25 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | http://www.genbody.co.kr |
GenBody Inc. | Seobuk-gu, Cheonan-si, Chungcheongnam | KR | IVC Pragen GmbH | MT Promedt Consulting GmbH | St.Ingbert | DE | GenBody-COVID-19 Ag | COVAG025 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | http://www.ivc-pragen.com\ivd |
GenBody Inc. | Seobuk-gu, Cheonan-si, Chungcheongnam | KR | IVC Pragen GmbH | MT Promedt Consulting GmbH | St.Ingbert | DE | GenBody Influenza/COVID-19 Ag Multi | CVIFG010 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | http://www.ivc-pragen.com\ivd |
GenBody Inc. | Seobuk-gu, Cheonan-si, Chungcheongnam | KR | ASCANUS Pharma GmbH | MT Promedt Consulting GmbH | St.Ingbert | DE | GenBody-COVID-19 Ag | COVAG025 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | http://www.ascanus.de/4_1_de.html |
GenBody Inc. | Seobuk-gu, Cheonan-si, Chungcheongnam | KR | ASCANUS Pharma GmbH | MT Promedt Consulting GmbH | St.Ingbert | DE | GenBody Influenza/COVID-19 Ag Multi | CVIFG010 | 90 | 73,47 - 97,89 | 98 | 92,96 - 99,76 | http://www.ascanus.de/4_1_de.html |
Bionote, Inc. | Hwaseong-si, Gyeonggi-do | KR | Concile GmbH | MT Promedt Consulting GmbH | St. Ingbert | DE | NowCheck COVID-19 Ag Test | DE/CA70/40838/156134 | 89,2 | 81,7 - 93,9 | 97,6 | 95,1 - 98,8 | https://bit.ly/3191UVD |
JOYSBIO (Tianjin) Biotechnology CO., LTD. | Tianjin | CN | Lotus NL B.V. | The Hague | NL | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) / Test Kit für neuartiges Coronavirus-Antigen (kolloidale Gold-Methode) | COV-AG-20 / G10313 | 88,89 | 75,9 - 96,3 | 99,05 | 94,8 - 100,0 | https://en.joysbio.com/wp-content/uploads/2020/10/JOYSBIO-SARS-COV-2-Antigen-Rapid-Test-Kit-IFU-German.pdf | |
PCL, Inc. | Geumcheon-gu, Seoul | KR | Datametrex AI Limited | DE | PCL COVID19 Ag Rapid FIA | 88,71 | 78,1 - 95,34 | 98,61 | 92,50 - 99,96 | ||||
Shenzhen Microprofit Biotech Co., Ltd | Shenzhen | CN | SVAN International Import & Export Co. Ltd. | CMC Medical Devices & Drugs SL | Malaga | ES | Fluorocare SARS-CoV-2 Spike Protein Test kit - Colloidal Gold | AG01CGS | 88,24 | 76,13 - 95,56 | 100 | 98,78 - 100 | https://3ps-medical-care.de/ |
Green Cross Medical Science Corp. | Geumwang-eup, Eumseong-gun | KR | N/A | MT Promedt Consulting GmbH | St. Ingbert | DE | GENEDIA W COVID-19 Ag | 643G | 87,25 | 79,2 - 93,0 | 100 | 97,2 - 100 | https://drive.google.com/file/d/1eZZEHoLs8S9-UutvAJ3LmWI1o_dk8eFl/view?usp=sharing |
TaiDoc Technology Corporation | New Taipei City | TW | EC-REP MedNet GmbH | Muenster | DE | VTRUST TD-4531 'COVID-19 Antigen Rapid Test' | 85,7 | 65,4 - 95,0 | 98,6 | 92,4 - 100 | https://www.dropbox.com/sh/yeycbehlb4tnily/AAC6Oq8o0_KY-mSXnX1dSTTga?dl=0 | ||
Guangdong Wesail Biotech Co., Ltd. | Dongguan, Guangdong | CN | Bio-Gram Diagnostics GmbH | Lotus NL B.V | Gravenhagen | NL | Covid-19 AG Test Kit | BE0040 | 82,5 | 68,05 - 91,25 | 98 | 96,36 - 98,91 | https://bio-gram.de/wp-content/uploads/2020/10/Packungsbeilage-COVID-19-Ag-Test-Kit.pdf |
Kommentar schreiben
GoaCDtTd (Sonntag, 18 September 2022 08:26)
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GoaCDtTd (Sonntag, 18 September 2022 08:42)
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GoaCDtTd (Sonntag, 18 September 2022 08:43)
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GoaCDtTd (Sonntag, 18 September 2022 08:44)
-1); waitfor delay '0:0:15' --
GoaCDtTd (Sonntag, 18 September 2022 08:44)
-5 OR 721=(SELECT 721 FROM PG_SLEEP(15))--
GoaCDtTd (Sonntag, 18 September 2022 08:45)
KgTCXfQ1' OR 278=(SELECT 278 FROM PG_SLEEP(15))--
GoaCDtTd (Sonntag, 18 September 2022 08:45)
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GoaCDtTd (Sonntag, 18 September 2022 08:46)
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0'XOR(if(now()=sysdate(),sleep(15),0))XOR'Z (Sonntag, 18 September 2022 08:58)
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1 waitfor delay '0:0:15' -- (Sonntag, 18 September 2022 08:59)
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Ud2Kj2D0') OR 732=(SELECT 732 FROM PG_SLEEP(15))-- (Sonntag, 18 September 2022 08:59)
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GoaCDtTd (Sonntag, 18 September 2022 09:00)
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GoaCDtTd (Sonntag, 18 September 2022 13:53)
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lxbfYeaa (Montag, 13 Februar 2023 02:17)
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lxbfYeaa (Montag, 13 Februar 2023 02:23)
if(now()=sysdate(),sleep(15),0)
lxbfYeaa (Montag, 13 Februar 2023 02:23)
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lxbfYeaa (Montag, 13 Februar 2023 02:24)
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lxbfYeaa (Montag, 13 Februar 2023 02:24)
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lxbfYeaa (Montag, 13 Februar 2023 02:25)
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lxbfYeaa (Montag, 13 Februar 2023 02:26)
1
lxbfYeaa (Montag, 13 Februar 2023 02:26)
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lxbfYeaa (Montag, 13 Februar 2023 02:27)
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lxbfYeaa (Montag, 13 Februar 2023 02:27)
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lxbfYeaa (Montag, 13 Februar 2023 02:35)
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0'XOR(if(now()=sysdate(),sleep(15),0))XOR'Z (Montag, 13 Februar 2023 02:36)
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lxbfYeaa (Montag, 13 Februar 2023 02:37)
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lxbfYeaa (Montag, 13 Februar 2023 02:38)
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