SARS-CoV-2-Antigenschnelltests
Übersicht zu derzeit verfügbaren zertifizierten SARS-CoV-2-Antigenschnelltests in Österreich
Zertifizierte Tests
Die Liste gibt einen Überblick über die derzeit in Österreich verfügbaren SARS-CoV-2-Antigenschnelltests die zur Eigenanwendung zertifiziert sind, erhebt jedoch keinen Anspruch auf Vollständigkeit. Bei diesen Tests erfolgte die Einbindung einer benannten Stelle als unabhängige Prüfinstanz, welche die Eignung zur Eigenanwendung der Tests bewertet. Auf den Produkten ist eine 4-stellige Nummer neben der CE-Kennzeichnung angebracht, mit der die involvierte Benannte Stelle identifiziert werden kann.
| Hersteller | Produktname | Name und Anschrift des Bevollmächtigten | Probennahme | REF |
| Acon Biotech (Hangzhou) Co, Ltd No.210 Zhenzhong Road, West Lake District, Hangzhou, P.R.China, 310030 | Flowflex SARS CoV-2 Antigen Rapid Test | MedNet EC-REP GmbH Borkstrasse 10, 48163 MÜNSTER, Germany | Anterio nasal swab | L031-11855 L031-118L5 L031-118T5 L031-118A5 L031-118U5 L031-118V5 L031-118Q5 L031-118M5 L031-118N5 L031-118W5 L031-118P5 L031-118Y5 L031-118Z5 L031-118R5 |
| Acon Biotech (Hangzhou) Co, Ltd No.210 Zhenzhong Road, West Lake District, Hangzhou, P.R.China, 310030 | DiaQuick SARS-CoV-2 Antigen Rapid Test | MedNet EC-REP GmbH Borkstrasse 10, 48163 MÜNSTER, Germany | Anterio nasal swab | L031-11853J L031-118A3J L031-118Q3J L031-118M3J L031-118P3J L031-118R3J |
| ACRO BIOTECH Inc. Address: 9500 7th Street, Unit M Rancho Cucamong,USA | COVID-19 Antigen Rapid Test(Oral Fluid) for self testing | Mednet EC-REP GmbH Borkstraße 10, 48163 Münster, Germany | Oral Fluid | ACO-1002 |
| Aesku.Diagnostics GmbH & Co.KG Mikroforum Ring 2 55234 Wendelsheim Deutschland | AESKU.RAPID SARS-CoV-2 | Bei einem in der europäischen Union niedergelassenen Hersteller ist ein Bevollmächtigter nicht vorgesehen. | anterior nasal | 840001E 840003E 840005E 840007E 840003K 840005K 840007K |
| Anhui Deepblue Medical Technology Co., Ltd. 4th Floor,D-1#Zone, Pearl Industrial Park, 106 Innovation Avenue, High-Tech Development Zone, 230088 Hefei, Anhui, China | COVID-19 (SARS-COV-2) Antigen Test Kit (Colloidal Gold) | LUXUS LEBENSWELT GMBH Kochstr. 1, 47877, Willich, Germany | nasal swab | SL030101NST-1,SL030101NST-2, SL030101NST-3, SL030101NST-5, SL030101NST-6, SL030101NST-7, SL030101NST-8, SL030101NST-9, SL030101NST-10, SL030101NST-11, SL030101NST-12, SL030101NST-15, SL030101NST-16, SL030101NST-17, SL030101NST-18, SL030101NST-19, SL030101NST-20, SL030101NST-25 |
| Assure Tech. (Hangzhou) Co., Ltd. Building 4, No. 1418-50, Moganshan Road, Gongshu District, Hangzhou, 310011 Zhejiang, P.R. China | SARS-CoV-2 Antigen Rapid Tests | Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands | Nasal swabs | |
| Assure Tech. (Hangzhou) Co., Ltd. Building 4, No. 1418-50, Moganshan Road, Gongshu District, Hangzhou, 310011 Zhejiang, P.R. China | COVID-19 Antigen Nasal Test Kit | Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands | nasal secretions | COV-S35002H1, COV-S35002H1, COV-S35002H2, COV-S35002H2, COV-S35002H3, COV-S35002H3, COV-S35002H4, COV-S35002H4, COV-S35002H5, COV-S35002H5, COV-S35002H6, COV-S35002H6, COV-S35002H7, COV-S35002H7, COV-S35002H8, COV-S35002H8, COV-S35002H9, COV-S35002H9, COV-S35002H10, COV-S35002H10, COV-S35002H15, COV-S35002H15, COV-S35002H20 |
| Beijing Applied Biological Technologies Co., Ltd. Address: Building 5 C101, Building 6 504, Building 7 304, No. 97, Changping Road, Shahe Town, 102206 Beijing, P.R.China | SARS-CoV-2 Antigen Rapid Test Cassette | Luxus Lebenswelt GmbH Address: Kochstr. 1, 47877, Willich, Germany | Anterior nasal swab | CG9011(S)-1T-AN,CG9011(S)-5T-AN,CG9011(S)-10TAN, CG9011(S)-20T-AN,CG9011(S)-30T-AN |
| Beijing Hotgen Biotech Co., Ltd. 9th Building, No. 9 Tianfu Street, Biomedical Base, Daxing District, Beijing, 102600, P.R. China. | Coronavirus (2019-nCoV)-Antigentest | MedNet GmbH Borkstrasse 10, 48163 Muenster, Germany | anterior nasal swab | HGCG134S0101 HGCG134S0105 HGCG134S0120 HGCG134S0140 |
| Beijing Lepu Medical Technology Co., Ltd；Building 7-1, No.37 Chaoqian Road, Changping District, 102200 Beijing, China | SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) | Lepu Medical (Europe) Cooperatief U.A.； Abe Lenstra Boulevard 36, 8448 JB, Heerenveen,The Netherlands | Nasal Swab | CG3601 CG3605 CG3610 CG3625 CG3650 |
| BioDetect（Xiamen）Biotechnology Co., Ltd. Gebäude B9, Xiamen Biomedical Industrial Park, 2066 Wengjiao West Road, Xiamen, Fujian, 361026, P.R. | RAPID SARS-COV-2 ANTIGEN TEST CARD | Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, Haia, Países Baixos | ANTERIOR NASAL | |
| Getein Biotech, Inc No.9 Bofu Road, Luhe District, Nanjing, 211505, China | One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | CMC Medical Devices & Drugs S.L. C/ Horacio Lengo No 18, CP 29006, Málaga, Spain | Nasal swab | CG20615 CG206152 CG206153 CG206155 CG206156 CG206157 CG206158 CG206159 CG2061510 CG2061512 CG2061515 CG2061520 CG2061525 |
| Guangdong Hecin Scientific, Inc. Floor 4, Building 1, #1 Ruifa Rd, Huangpu District, Guangzhou, 510530, Guangdong, P.R. China. | 2019-nCoV Antigen Test Kit (colloidal gold method) | PureCE B.V. Westplein 12 3016 BM, Rotterdam Netherlands | JT11-1 JT11-5 JT11-20 | |
| Guangzhou Decheng Biotechnology Co.,LTD Room 218 and Room 212, Building 2, No. 68, Nanxiang 1st Road Science City, Huangpu District, Guangzhou, Guangdong, m 510663, P.R. China | 2019-nCoV Ag Speichel Schnelltestkarte (Immunchromatographie) | Caretechion GmbH Niederrheinstr. 71 40474 Düsseldorf, Germany | Saliva | 0699C8X001 0699C8X005 0699C8X020 |
| Guangzhou Wondfo Biotech Co., Ltd. No.8, Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. China | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Qarad EC-REP BV Pas 257, 2440 Geel, Belgium | Nasentupferprobe (nasal swab) | W634P0024, W634P0028, W634P0029, W634P0025, W634P0026, W634P0027 |
| Guangzhou Wondfo Biotech Co., Ltd.; No. 8 Lizhishan Road, Science City, 510663 Guangzhou, China | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Qarad EC-REP BV, Pas 257, 2440 Geel, Belgium | nasaler Abstrich | W634P0024 |
| HANGZHOU ALLTEST BIOTECH CO., LTD, 550#, Yinhai Street, Hangzhou Economy and Technology Development Area Hangzhou, P. R. China 310018 | GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) | MedNet GmbH Borkstrasse 10 48163 Muenster Germany | Nasal Swab | CVAG502H05 |
| Hangzhou AllTest Biotech Co., Ltd. Address: 550 Yinhai street,Hangzhou Economic and Technologic Development Area, China | COVID-19 Antigen Rapid Test (Oral Fluid) | MedNet GmbH Address: Borkstrasse 10, Muenster Germany | Oral Fluid | ICOV-802H |
| Hangzhou AllTest Biotech Co., Ltd. Address: 550 Yinhai street,Hangzhou Economic and Technologic Development Area, China | SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | MedNet GmbH Address: Borkstrasse 10, Muenster Germany | Nasal Swab | INCP-502H |
| Hangzhou Clongene Biotech Co., Ltd. ;No.1 Yichuang Road, Yuhang Sub-district, Yuhang District, 311121 Hangzhou, China | COVID-19 Antigen Rapid Test | Shanghai International Holding Corp. GmbH (Europe); Authorized representativeAddress: Eiffestrasse 80, D-20537 Hamburg, Germany | Nasal Swab | ISCOVu002-A001; ISCOVu002-A005; ISCOVu002-A025; ISCOVu002-B001; ISCOVu002-B005; ISCOVu002-B025 |
| Hangzhou Sejoy Electronics & Instruments Co.,Ltd. Area C,Building 2,No.365,Wuzhou Road,Yuhang Economic Development Zone,311100 Hangzhou City,Zhejiang,China | SARS-CoV-2 Antigen Rapid Test Cassette | Shanghai International Holding Corp.GmbH (Europe) | Nasal swab | COVG-602ST |
| Hangzhou Sejoy Electronics & Instruments Co.,Ltd. Area C,Building 2,No.365,Wuzhou Road,Yuhang Economic Development Zone,311100 Hangzhou City,Zhejiang,China | SARS-CoV-2 Antigen Rapid Test Cassette | Shanghai International Holding Corp.GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany | Nasal swab | COVG-602ST |
| INNOVITA (Tangshan) Biological Technology Co., Ltd. No. 699 Juxin Street, High-tech Industrial Development Zone, Qian’an, Hebei, 064400, China | 2019-nCoV Ag Test (Latex Chromatography Assay) | Osmunda Medical Technology Service GmbH Treskowallee 108, 10318 Berlin, Germany | This kit is limited to testing human anterior nasal swabs. | |
| Jiangsu Bioperfectus Technologies Co., Ltd. 3rd and 4th floors of Building A(G19), 4th floor of Building F(G14), Ground floor of Building G20, Shuaiyu Village, Fuye village, Sixiang town, Taizhou National Medical, Hi-tech Development Zone, 225300 Taizhou, Jiangsu, PEOPLE'S REPUBLIC OF CHINA | Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (self-test) | MedNet EC-REP GmbH, Borkstrasse 10, 48163 Muenster, Germany | Anterio nasal swab | SC30107SW-1T SC30107SW-2T SC30107SW-5T SC30107SW-10T SC30107SW-15T |
| Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. Address: No. 888, Zhujiang Road, Juegang Street, Rudong County (Life and Health Industrial Park of Rudong High-tech Zone) 226499 Nantong city, Jiangsu Province, PEOPLE’S REPUBLIC OF CHINA | SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal | CMC Medical Devices & Drugs S.L Address: C/Horacio Lengo Nº 18 CP 29006, Málaga-Spanien | Nasal | HWTS-RT062I, HWTS-RT062IA, HWTS-RT062IB, HWTS-RT062IC |
| Jiangsu Medomics Medical Technology Co., Ltd F3, Building C, No.3-1 Xinjinhu road, Jiangbei new area Nanjing, Jiangsu, CHINA | SARS-CoV-2 Antigen Test Kit (LFIA) | R. Sight B.V. Adresse: Roald Dahllaa 47, 5629 MC, Eindhoven, Niederlande | Anterior Nasal / Vordere Nase | 1031-14-01, 1031-34-01, 1031-54-01 |
| Joinstar Biomedical Technology Co. Ltd. NO.519 XingGuo RD, Yuhang Economic and Technological Development Zone Hangzhou China | COVID-19 Antigen Rapid Test (Colloidal Gold) anterior nasal – self testing device | Lotos NL B.V. Konigin Julianaplein 10, 1e Verd 2595AA The Hague Netherlands | Anterior Nasal | FGCOVG7100 FGCOVG7200 FGCOVG7300 FGCOVG7400 |
| JOINSTAR BIOMEDICAL TECHNOLOGY CO., LTD. NO.519 Xingguo RD. Yuhang Economic and Technological Development Zone, Hangzhou, Zhejiang, China | COVID-19 Antigen Rapid Test (Colloidal Gold) anterior nasal – self testing device | Lotos NL B.V. Konigin Julianaplein 10, 1e Verd 2595AA The Hague Netherlands | vorderer Nasenabstrich | FGCOVG7100 FGCOVG7200 FGCOVG7300 FGCOVG7400 |
| MP Biomedicals Germany GmbH Thüringer Straße 15 37269 Eschwege Deutschland | Rapid SARS-CoV-2 Antigen Test Card | Bei einem in der europäischen Union niedergelassenen Hersteller ist ein Bevollmächtigter nicht vorgesehen. | anterioren Nasenabstriches | 07AG6001BS 07AG6005BS 07AG6007BS 07AG6020BS |
| NanoRepro AG Untergasse 8 35037, Marburg Deutschland | NanoRepro SARS-CoV-2 Antigen Rapid Test | Bei einem in der europäischen Union niedergelassenen Hersteller ist ein Bevollmächtigter nicht vorgesehen. | Nasal swabs | B60910 B60950 B60920 B60300 B60500 B60400 |
| NanoRepro AG Untergasse 8 35037, Marburg | ZuhauseTEST Corona | Bei einem in der europäischen Union niedergelassenen Hersteller ist ein Bevollmächtigter nicht vorgesehen. | Saliva | B60200 |
| New Gene (Hangzhou) – Bioengineering Co., Ltd. Room 1606, Floor 16, Building 5,688 Bin'an Road, Changhe Street, Binjiang District, Hangzhou City, Zhejiang Province, P. R. China | COVID-19 Antigen Detecton Kit – Nasal Swab | SUNGO Europe B.V. Olympisch Stadion 24, 1076DE Amsterdam, Netherlands | nasale Abstrichproben | |
| Qingdao Hightop Biotech Co., Ltd. Add.: No.369 Hedong Road, Hi-tech Industrial Development Zone, Qingdao,Shandong,266112, China | SARS-CoV-2 Antigen Rapid Test | MedNet EC-REP GmbH Borkstrasse 10, 48163 Muenster, Germany | vorderer Nasenabstrich | |
| Sansure Biotech Inc., No. 680, Lusong Road, Yuelu District, 410205 Changsha, Hunan Province, PEOPLE’S REPUBLIC OF CHINA | SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) | Obelis S.A, Bd. Général Wahis 53, 1030 Brussels, BELGIUM | Nasal swab | |
| SD Biosensor; Inc. 74, Osongsaengmyeong 4-ro, Osong-eup, Heungedeok-gu, Cheongju-si, Chungcheongbuk-do 28161, Korea | SARS-CoV-2 Antigen Selbsttest Nasal | MT Promedt Consulting GmbH, Altenhofstraße 80, 66386 St. Ingbert, Deutschland | Nasal | 9445323023 |
| Shenzhen Microprofit Biotech Co., Ltd.(Address: Rm. 405, 406, Zone B /4F, Rm. 205, 206-1, 207, West Side of Zone B/ 2F, Haowei Building, No. 8 Langshan 2nd Road, Songpingshan, Songpingshan Community, Xili Street, Nanshan District, Shenzhen, P.R. China) | SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) REF: MF-68 | CMC MEDICAL DEVICES & DRUGS, S.L. Address: C/ Horacio Lengo n18·C.P 29006 · Málaga-Spain | nasal swab | MF-68 |
| VivaChek Biotech (Hangzhou) Co., Ltd. Level 2, Block 2, 146 East Chaofeng Rd, Yuhang Economy Development Zone, Hangzhou, Zhejiang 311100, China | VivaDiagTM Pro SARS-CoV-2 Ag Rapid Test | Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. | anterior nasal | VCD16-10-013 VCD16-10-015 VCD16-10-014 VCD16-10-011 |
| VivaChek Biotech (Hangzhou) Co., Ltd. Level 2, Block 2, 146 East Chaofeng Rd, Yuhang Economy Development Zone, Hangzhou, Zhejiang 311100, China | Verino® Pro SARS-CoV-2 Ag Rapid Test | Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. | anterior nasal | VCD16-10-043 VCD16-10-045 VCD16-10-044 VCD16-10-041 |
| Wuhan EasyDiagnosis Biomedicine Co., Ltd. Room 3 & 4, 2nd Floor, Bldg 25, Phase 3.1, Wuhan Optics Valley International Biopharmaceu- tical Enterprise Accelerator, No. 388, Gaoxin 2nd Road, East Lake Hi-Tech Development Zone, Wuhan, 430074, Hubei, P.R. China. | COVID-19(SARS-CoV-2) Antigen test kit | Osmunda Medical Technology Service GmbH Treskowallee 108, 10318 Berlin, Germany | Nasal Swabs | W-AgH-01S W-AgH-01 W-AgH-05S W-AgH-05 W-AgH-07 W-AgH-07S W-AgH-08S W-AgH-08 W-AgH-10S W-AgH-10 W-AgH-15S W-AgH-15 W-AgH-20S W-AgH-20 W-AgH-25S W-AgH-25 |
| Xiamen Boson Biotech Co., Ltd. 90-94 Tianfeng Road, Jimei North Industrial Park, Xiamen, Fujian, 361021, P.R.China. | Rapid SARS-CoV-2 Antigen Test Card | Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. | Anterio nasal swab | 1N40C5-2 1N40C5-4 1N40C5-6 |
| Xiamen Wiz Biotech Co.,LTD. 3-4 Floor, No.16 Building, Bio-medical, 2030 Wenjiao West Road, Haicang District, 361026, Xiamen, China | WIZBIOTECH SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Qarad EC-REP BV Pas 257, 2440 Geel, Belgium | Anterior Nasal | 51332801 51332802 51332803 51332804 |
| Zybio Inc. Address: Floor 1 to Floor 5, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, PEOPLE’S REPUBLIC OF CHINA | SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method) | Shanghai International Holding Corp. GmbH (Europe) Address: Eiffestrasse 80, 20537 Hamburg, Germany | Anterior nasal swab sampling | 2061702, 2061703, 2061704 |
Aufnahme in die Liste
Hersteller von zertifizierten SARS-CoV-2-Antigenschnelltest zur Eigenanwendung, die Ihr Produkt in Österreich in Verkehr bringen und in diese Liste aufgenommen werden wollen, werden ersucht folgende Informationen zu übermitteln:
- Handelsname des SARS-CoV-2 Antigenschnelltest
- Anschrift und Name des Herstellers
- Anschrift und Name des Bevollmächtigten
- Konformitätserklärung und Zertifikat der benannten Stelle
- Art der Probenentnahme
Bitte übermitteln Sie die Daten per E-Mail an medizinprodukte@basg.gv.at mit dem Betreff „Zertifizierte SARS-CoV-2-Antigentests zur Eigenanwendung".
Haftungsausschluss: Diese Listen erheben keinen Anspruch auf Vollständigkeit. Die Angaben werden ohne weitere Prüfung durch das BASG übernommen. Für Fragen bezüglich der Funktionsweise und Sicherheit der Tests ersuchen wir Sie, die Hersteller direkt zu kontaktieren.
Rückfragehinweis
Letzte Änderung am:
09.05.2022