ReagentsInfectious diseases

Retroviruses (infect. immunology/NAT)

EMDN code W010503

34 manufacturers, 99 models including 96 on the market, 15 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 34

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
Biolytical FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	48 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1026-00198/79 48 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1026-00298/79 48 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1026-00398/79 INSTI HIV ANTIBODY SELF-TEST 90-1058-001 and 90-1058-00298/79 INSTI HIV ANTIBODY SELF-TEST 90-1123-00198/79 31 others INSTI HIV ANTIBODY SELF-TEST 90-1126-001 and 90-1126-00298/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105098/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105698/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105798/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105898/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105998/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-1059-001 and 90-1059-00298/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-106098/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-1060-001, 90-1060-002, 90-1060-003, and 90-1060-00498/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-106398/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-107698/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-1076-003 and 90-1076-00498/79 INSTI HIV Self Test (no pipette variant, packaged in a box)) 90-1076-005 and 90-1076-00698/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-001 and 90-1041-00298/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-003 and 90-1041-01098/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-00798/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-014 and 90-1041-01598/79 INSTI HIV Self Test (no pipette variant, packaged in pouch) 90-1041-012 and 90-1041-01398/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-001 and 90-1015-00298/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-003 and 90-1015-00498/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-005 and 90-1015-00698/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-00898/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-00998/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-01098/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-011 and 90-1015-01298/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-013 and 90-1015-01498/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-015 and 90-1015-01698/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-017 and 90-1015-01898/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-102698/79 INSïl HIV Self Test (no pipette variant, packaged in a box) 90-1056-001 and 90-1056-00298/79 INSïl HIV Self Test (no pipette variant, packaged in a box) 90-1057-001 and 90-1057-00298/79	– 98/79	EUDAMED record Report an error
Atomo Diagnostics EU representative : QbD RepS BV (Belgium)	Australia	ARST001-0298/79 ARST001-0498/79 ARST001-0598/79 Newfoundland HIV Self Test NFLD001-0198/79 NFLD001-0298/79 2 others NFLD001-0398/79 Simplitude ByMe Galileo Platform2 refs98/79 (no longer marketed)	– 98/79	Website info@atomodiagnostics.com EUDAMED record Report an error
Denizbiyokimya	Türkiye	INNOVIQURE HIV 1/2 Ab Reagent Kit 100T98/79 INNOVIQURE HIV 1/2 Ab Reagent Kit 200T98/79 INNOVIQURE HIV 1/2 Ab Reagent Kit 400T98/79 INNOVIQURE HIV Combo Ag/Ab Reagent Kit 100T98/79 INNOVIQURE HIV Combo Ag/Ab Reagent Kit 400T98/79 1 other INNOVIQURE HTLV I/II Ab Reagent Kit 100T98/79	– 98/79	EUDAMED record Report an error
Ablsa	Luxembourg	DeepChek® Assay INTEGRASE Genotyping and Drug Resistance V1.X98/79 DeepChek® Assay INTEGRASE Sequencing V1.X98/79 DeepChek® Assay PROTEASE / REVERSE TRANSCRIPTASE Genotyping and Drug Resistance V1.X98/79 DeepChek® Assay PROTEASE / REVERSE TRANSCRIPTASE Sequencing V1.X98/79 DeepChek® Assay Whole Genome HIV-1 Genotyping V1.X98/79	– 98/79	Website contact@ablsa.com EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx HIV-1 qPCR Kit6 refs98/79 RevoDx HIV-1/2 qPCR Kit2 refs98/79 RevoDx HIV-2 qPCR Kit4 refs98/79	– 98/79	Website EUDAMED record Report an error
Mpbio FDA EU representative : MP Biomedicals Germany GmbH (Germany)	Singapore	MP Diagnostics HIV Ag/Ab Combo ELISA 4.0 23040-09698/79 MP Diagnostics HIV Ag/Ab Combo ELISA 4.0 23040-48098/79 MP Diagnostics MULTISURE HIV 1/2 Confirmatory Test98/79	– 98/79	EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium)	China	ITP02153-TC1098/79 ITP02153-TC4098/79 ITP02152-TC2598/79 (no longer marketed) ITP02152-TC4098/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Beijing Wantai Biological Pharmacy Enterprise EU representative : QbD RepS BV (Belgium)	China	AiD HIV 1+2 Ag/Ab ELISA Plus2 refs98/79 AiD anti-HIV 1+2 ELISA2 refs98/79	– 98/79	EUDAMED record Report an error
Bio-Rad FDA	France	Access HIV combo V2 C2843098/79 Geenius HIV 1/2 Confirmatory Assay 7246098/79	– 98/79	Website contact@bio-rad.com EUDAMED record Report an error
Bioneer FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	AccuPower® HIV-1 Quant Kit (ExiStation™ FA 96) AccuPower® HIV-1 Quantitative RT-PCR Kit98/79	D IVDR, 98/79	Website sales@bioneer.com EUDAMED record Report an error
Cepheid FDA	Sweden	Xpert® HIV-1 Qual XC98/79 Xpert® HIV-1 Viral Load XC98/79	– 98/79	Website EUDAMED record Report an error
Diagnostic Systems	Germany	abia HIV AgAb DK.003.01.398/79 abia HIV AgAb DK.003.05.398/79	– 98/79	Website info@ab-ds.de EUDAMED record Report an error
Dialab	Austria	HIV 1&2 Ab, cut-off2 refs98/79 HIV 1&2 Ag/Ab2 refs98/79	– 98/79	Website office@dialab.at EUDAMED record Report an error
Geneproof	Czechia	GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit2 refs98/79 TaqPath™ Menu GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit98/79	– 98/79	Website support@geneproof.com EUDAMED record Report an error
RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi	Türkiye	RTA HIV-1 Real Time PCR Kit2 refs98/79 RTA HIV-1 Real Time PCR Kit v2.03 refs98/79	– 98/79	Website EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany)	United States	ABBOTT REALTIME HIV-15 refs	D IVDR	EUDAMED record Report an error
Adaltis	Italy	EIAgen Detect HIV Combo Kit ++M52108131C98/79	– 98/79	Website info@adaltis.net EUDAMED record Report an error
altona Diagnostics FDA	Germany	AltoStar® HIV RT-PCR Kit 1.598/79	– 98/79	info@altona-diagnostics.com EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks Bosphore HIV-1 Quantification Kit3 refs98/79	– 98/79	Website info@anatoliagenetik.com EUDAMED record Report an error
Arrow Diagnostics	Italy	AD4SEQ HIV-1 SOLUTION V2	C IVDR	Website info@arrowdiagnostics.it EUDAMED record Report an error
Diapro	Italy	HIV Ag/Ab ELISA 5121498/79	– 98/79	Website info@diapro.it EUDAMED record Report an error
ElitechGroup FDA	Italy	HIV1 ELITe MGB® Kit	D IVDR	Website EUDAMED record Report an error
FlashDx Shenzhen EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	MRSA/SA Test B-MARSA-10NU98/79	– 98/79	info@flash-dx.com EUDAMED record Report an error
General Biologicals EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Taiwan	GB HIV Ag-Ab COMB2 refs98/79	– 98/79	sales.group@gbc.com.tw EUDAMED record Report an error
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH	Germany	PoET HIV98/79	– 98/79	Website info@gfeblut.de EUDAMED record Report an error
Hain Lifescience	Germany	GENERIC HIV-1 VIRAL LOAD VER 2.0	D IVDR	EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Aptima HIV-1 Quant Dx Assay3 refs	D IVDR	EUDAMED record Report an error
Iontek	Türkiye	Fluorion HIV-1 QNP 1.1 Real-Time PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Mikrogen	Germany	recomLine HTLV-1 & HTLV-2 IgG98/79	– 98/79	EUDAMED record Report an error
Roche FDA	Germany	Elecsys HTLV-I/II3 refs	D IVDR	Website EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United States	ADVIA Centaur CHIV IVDR_67_TTN_DUB-C_D_KIT_HIV Ag/Ab Combo2 refs	D IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Thermofisher FDA EU representative : Life Technologies Europe B.V. (Netherlands)	United States	HIV-1 Genotyping Kit A5440198/79	– 98/79	EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany)	Singapore	Sentosa SQ HIV Genotyping Assay (4x16) 69003798/79	– 98/79	Website infoAPAC@veladx.com EUDAMED record Report an error

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