Infectious diseasesInfectious immunology - rapid tests & point of careRetroviruses RT & POC

HIV 1 / 2 - RT & POC

EMDN code W0105090302

18 manufacturers, 64 models including 62 on the market, 10 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 18

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Orasure FDA EU representative : QbD RepS BV (Belgium)	United States	OraQuick HIV Self-Test 1001-060098/79 OraQuick HIV Self-Test 1001-0600U98/79 OraQuick HIV Self-Test 1001-060198/79 OraQuick HIV Self-Test 1001-0601U98/79 OraQuick HIV Self-Test 1001-060298/79 13 others OraQuick HIV Self-Test 1001-0602U98/79 OraQuick HIV Self-Test 1001-060398/79 OraQuick HIV Self-Test 1001-0603U98/79 OraQuick HIV Self-Test 1001-062798/79 OraQuick HIV Self-Test 1001-0627U98/79 OraQuick HIV Self-Test 1001-062898/79 OraQuick HIV Self-Test 1001-0628U98/79 OraQuick HIV Self-Test 1001-062998/79 OraQuick HIV Self-Test 1001-0629U98/79 OraQuick HIV Self-Test 1001-063098/79 OraQuick HIV Self-Test 1001-0630U98/79 OraQuick HIV Self-Test 1001-070698/79 (no longer marketed) OraQuick HIV Self-Test 1001-0706U98/79 (no longer marketed)	– 98/79	Website customercare@orasure.com EUDAMED record Report an error
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Germany, South Korea	Bioline™ HIV 1/2 3.0 03FK10CE2 refs98/79 Bioline™ HIV 1/2 3.0 03FK16CE2 refs98/79 CheckNow™ 455340902398/79 CheckNow™ 456342902398/79 CheckNow™ 456381902398/79 6 others Panbio™ 455556902298/79 Panbio™ 455996902298/79 Panbio™ 455997902298/79 Panbio™ 456339902298/79 Panbio™ 456340902298/79 Panbio™ 456751902298/79	– 98/79	Website EUDAMED record Report an error
PRIMA Lab EU representative : QbD RepS BV (Belgium)	Switzerland	800062-x98/79 Autotest HIV 1/298/79 GetTested HIV TEST98/79 HIV 1/2 SELF-TEST98/79 Horny Hive HIV Selbsttest98/79 2 others PRIMA HOME TEST HIV 1/2 SELF-TEST98/79 Veneris Test rapid HIV 1&298/79	– 98/79	quality@primahometest.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Hexagon HbsAg98/79 Hexagon HIV98/79 HIV 1.2 Rapid Test Cassette2 refs98/79 HIV 1.2 Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HIV 1.2.O Rapid Test Cassette(WB/S/P)98/79 1 other Teste rápido em cassete de HIV 1.2(Sangue Total/Soro/Plasma)98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Türkiye	Anti-HIV 1/2 Test7 refs98/79 Anti-HIV 1/2 Test Eco98/79 Anti-HIV 1/2 Test Plus98/79 Anti-HIV 1/2 Test Pro98/79 Anti-HIV 1/2 Test Single2 refs98/79	– 98/79	Website info@turklab.com.tr EUDAMED record Report an error
Meril Diagnostics FDA EU representative : Obelis s.a. (Belgium)	India	HIVFIND HIVSST-013 refs HIVWBS-01 HIVWBS-02 HIVWBS-03 HIVWBS-043 refs MERISCREEN HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 HVWRPD-08 HVWRPD-09 HVWRPD-10 HVWRPD-11 HVWRPD-123 refs	D IVDR	Website ram.kanoje@merillife.com EUDAMED record Report an error
Artronlab FDA EU representative : MedNet EC-REP GmbH (Germany)	Canada	Acmex Human Immunodeficiency Virus 1/2 (HIV1/2) Antibody Test Cassette2 refs Artron Human lmmunodeficiency Virus 1/2 (HMl2l Antibody Test Cassette98/79	D IVDR, 98/79	Website info@artronlab.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	HIV 1/2 Human Immunodeficiency Virus Rapid Test (Serum/Plasma)(Cassette) GCHIV-302a98/79 HIV 1/2 Human Immunodeficiency Virus Rapid Test st (Whole blood/Serum/Plasma)(Cassette) GCHIV-402a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Aaz Productions Le Materiel Biomedical	France	autotest VIH® 2nd GENERATION3 refs	D IVDR	EUDAMED record Report an error
Abon Biopharm(Hangzhou) EU representative : Medical Technology Promedt Consulting GmbH (Germany)	China	IHI-T40298/79	– 98/79	EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	ACON HIV 1/2/O Tri-line Rapid Test Cassette (Serum/Plasma/Whole blood)3 refs	D IVDR	Website EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)98/79	– 98/79	Website contact@diareagent.com EUDAMED record Report an error
Cupidlimited FDA EU representative : Amstermed B.V. (Netherlands)	India	CupiKIT HIV 1 & 2 Antibody Test Kit	D IVDR	Website qa@cupidlimited.com EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	RightSign IHIV-C4298/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Mpbio FDA EU representative : MP Biomedicals Germany GmbH (Germany)	Singapore	MP Diagnostics MULTISURE HIV Rapid Test98/79	– 98/79	EUDAMED record Report an error
Newscen EU representative : Wellkang Ltd (Northern Ireland)	China	HIV3-292040170003 refs	D IVDR	Website EUDAMED record Report an error
Premier Medical EU representative : Obelis s.a. (Belgium)	India	First Response HIV 1-2.O Card Test (Version 2.0 PI05FRC4 refs98/79	– 98/79	Website info@premiermedcorp.com EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium)	China	Wondfo One Step HIV1/2 Whole Blood/Serum/Plasma Test2 refs	D IVDR	Website sales@wondfo.com.cn EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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