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TaqPath™ Menu | GeneProof™ Hepatitis C Virus (HCV) Diagnostic PCR Kit

GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304348
Basic UDI-DI: B-08595696304348
Reference: A58427
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161956914
Basic UDI-DI: B-08594161956914
Reference: HCVD/ISEX/025
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

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GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161956891
Basic UDI-DI: B-08594161956891
Reference: HCVD/ISEX/100
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

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HCV Rapid Test Device (Serum/Plasma/Whole blood)

A510501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753475935
Basic UDI-DI: B-06976753475935
Reference: A510501D
EMDN: W0105020301
EMDN description: HCV ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details

HCV Rapid Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-06936983106009W4
Basic UDI-DI: B-06936983106009W4
Reference: IHC-402
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HCV ANTIBODY TEST

90-1062-005 and 90-1062-006

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200704
Basic UDI-DI: B-00686597200704
Reference: 90-1062-005 and 90-1062-006
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HCV ANTIBODY TEST

90-1062-001, 90-1062-002, 90-1062-003

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200674
Basic UDI-DI: B-00686597200674
Reference: 90-1062-001, 90-1062-002, and 90-1062-003
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

MERISCREEN HCV

RPDHCV-01 RPDHCV-03

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 18906074563610
Basic UDI-DI: 8905459MHCVRT9A
Reference: RPDHCV-01 RPDHCV-03
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Germany
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/019 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

08033629923902

GEN-C Real Time

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629923902
Basic UDI-DI: 803362992GENHCVRT3H
Reference: AA1441/48
EMDN: W0105020309
EMDN description: HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:39

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06970301452454

AiD anti-HCV ELISA Plus

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452454
Basic UDI-DI: B-06970301452454
Reference: WC-31S480
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Hungary
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:25

Manufacturer products Authorised representative products Authorised representative actors View details

06970301452447

AiD anti-HCV ELISA Plus

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452447
Basic UDI-DI: B-06970301452447
Reference: WC-31S96
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Hungary
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:25

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731141
Basic UDI-DI: B-06955792731141
Reference: S3119E-24
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis C Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731127
Basic UDI-DI: B-06955792731127
Reference: S3034E
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

HCV Rapid Test

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983106009
Basic UDI-DI: B-06936983106009
Reference: IHC-402
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.06.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804313

IVD Annex II List ANot specifiedNo longer on the marketSingle useSterile

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804313
Basic UDI-DI: B-06936155804313
Reference: ITP01153-TC40
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804306

IVD Annex II List ANot specifiedOn the marketSingle useSterile

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804306
Basic UDI-DI: B-06936155804306
Reference: ITP01153-TC10
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804290

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804290
Basic UDI-DI: B-06936155804290
Reference: ITP01152-TC40
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804283

IVD Annex II List ANot specifiedNo longer on the marketSingle useSterile

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804283
Basic UDI-DI: B-06936155804283
Reference: ITP01152-TC25
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

PoET HCV

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370032
Basic UDI-DI: B-04262353370032
Reference: P2A-28-30
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

Manufacturer products View details