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Herpes Simplex Virus-Ⅱ IgG(HSV-Ⅱ IgG) Assay Reagent Kit(CMIA)

C2KL002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053618
Basic UDI-DI: B-06971792053618
Reference: C2KL002
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus -Ⅰ IgG (HSV-Ⅰ IgG) Assay Reagent Kit (CMIA)

C2KL001

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053571
Basic UDI-DI: B-06971792053571
Reference: C2KL001
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

VZV/HSV2/HSV1 Multiplex Real Time PCR Kit

VZV/HSV2/HSV1 Multiplex Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229497
Basic UDI-DI: B-06971042229497
Reference: SD-0314-02
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

HSVI&II Typing Real Time PCR Kit

HSVI&II Typing Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229442
Basic UDI-DI: B-06971042229442
Reference: SD-0136-02
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

HSVⅠ&Ⅱ Real Time PCR Kit

HSVⅠ&Ⅱ Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229411
Basic UDI-DI: B-06971042229411
Reference: SD-0017-02
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

Human Herpers Virus (HHV-8) Real Time PCR Kit

Human Herpers Virus (HHV-8) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229145
Basic UDI-DI: B-06971042229145
Reference: OD-0212-02
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details

Human Herpers Virus (HHV-6) Real Time PCR Kit

Human Herpers Virus (HHV-6) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229138
Basic UDI-DI: B-06971042229138
Reference: OD-0169-02
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details

FluoroType® HSV VER 1.0

FluoroType® HSV VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002870
Basic UDI-DI: B-04049055002870
Reference: 61224
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

Aptima Herpes Simplex Viruses 1 & 2 Assay

Aptima Herpes Simplex Viruses 1 & 2 Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045507210
Basic UDI-DI: 54200455DIAGAPTHSV12S7
Reference: PRD-03568
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details

GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit

GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300227
Basic UDI-DI: 859569630008QH
Reference: HSV/GP/100
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:58

Manufacturer products View details

GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit

GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300210
Basic UDI-DI: 859569630008QH
Reference: HSV/GP/025
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:58

Manufacturer products View details

CHORUS HERPES SIMPLEX 1 IgG RECOMBINANT

CHORUSHSV

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891328689
Basic UDI-DI: 803389132CHORUSHSV00BE
Reference: 81023
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

CHORUS HERPES SIMPLEX 1+2 IgM

CHORUSHSM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322229
Basic UDI-DI: 803389132CHORUSHSM009Z
Reference: 81021
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

CHORUS HERPES SIMPLEX 1+2 IgG

CHORUSHSG

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322212
Basic UDI-DI: 803389132CHORUSHSG0093
Reference: 81020
EMDN: W0105040303
EMDN description: HSV 1+2 IGG
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:42

Manufacturer products View details

EasyNAT HSV 1&2 Assay

EasyNAT HSV 1&2 Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240152
Basic UDI-DI: 697349224U2030042C000FJ
Reference: U20304
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus Type I and Type II Typing Nucleic Acid Detection Kit (Fluorescent Probe-Based Real-Time PCR Assay)

IVD generalIVDDOn the marketProfessional testingReagentSterile

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895476027
Basic UDI-DI: B-06970895476027
Reference: S073T050B0C0
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Greece
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 09:56

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-2 IgG CLIA Microparticles

Autolumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908898
Basic UDI-DI: 697015090000108H5
Reference: CMK1002
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1 IgG CLIA Microparticles

Autolumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908881
Basic UDI-DI: 697015090000107H3
Reference: CMK0902
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-2 IgM CLIA Microparticles

Autolumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908843
Basic UDI-DI: 697015090000103GT
Reference: CMK0502
EMDN: W0105040310
EMDN description: HSV 2 IGM
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1 IgM CLIA Microparticles

Autolumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908836
Basic UDI-DI: 697015090000102GR
Reference: CMK0402
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details