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330 device results listed.

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MONO-VIDITEST anti-HSV 1+2 IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 18594036041414
Basic UDI-DI: B-18594036041414
Reference: K-141-12
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

Manufacturer products View details

MONO-VIDITEST anti-HSV 1+2 IgG

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 18594036041407
Basic UDI-DI: B-18594036041407
Reference: K-140-12
EMDN: W0105040303
EMDN description: HSV 1+2 IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

Manufacturer products View details

Sentosa SA HSV1/2 Controls Set (8x3)

300686

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953695
Basic UDI-DI: B-08885013953695
Reference: 300686
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA HSV1/2 PCR Test (4x48)

300671

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953671
Basic UDI-DI: B-08885013953671
Reference: 300671
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA HSV1/2 Quantitation Standards (2x13)

300071

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953305
Basic UDI-DI: B-08885013953305
Reference: 300071
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA HSV1/2 Quantitation Controls (4x2)

300072

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953251
Basic UDI-DI: B-08885013953251
Reference: 300072
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA HSV1/2 PCR Test (4x24)

300233

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953237
Basic UDI-DI: B-08885013953237
Reference: 300233
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

SOFTEC Herpes Simplex Virus (HSV-1 & HSV-2) Qualitative RT-qPCR Detection Kit

ZT-HSV-01-100

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616541
Basic UDI-DI: B-08697962616541
Reference: ZT-HSV-01-100
EMDN: W0105040399
EMDN description: HSV REAGENTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 09.07.2026 07:22

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ChainFor HSV-6 Detection qPCR Kit

CFP115

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034873
Basic UDI-DI: B-08684595034873
Reference: CFP114
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:16

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RevoDx HSV-2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213516
Basic UDI-DI: B-08684387213516
Reference: IP202233-25
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:57

Manufacturer products View details

RevoDx HSV-1 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213509
Basic UDI-DI: B-08684387213509
Reference: IP202232-25
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:57

Manufacturer products View details

LyoSens Genital Ulcer Genotyping qPCR Kit

LYO55

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259769
Basic UDI-DI: B-08683548259769
Reference: LYO55
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:21

Manufacturer products View details

HSV-1 IgG CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552219
Basic UDI-DI: 697015090000107H3
Reference: CMK0905
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1 IgM CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552264
Basic UDI-DI: 697015090000102GR
Reference: CMK0405
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-2 IgG CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552318
Basic UDI-DI: 697015090000108H5
Reference: CMK1005
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-2 IgM CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552363
Basic UDI-DI: 697015090000103GT
Reference: CMK0505
EMDN: W0105040310
EMDN description: HSV 2 IGM
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

TaqPath™ Menu | GeneProof™ Herpes Simplex Virus (HSV-1/2) PCR Kit

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

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304065
Basic UDI-DI: B-08595696304065
Reference: A58128
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

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

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301156
Basic UDI-DI: B-08595696301156
Reference: HSV/MC/205
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:58

Manufacturer products View details

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

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301149
Basic UDI-DI: B-08595696301149
Reference: HSV/MC/041
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:58

Manufacturer products View details

ELISA-VIDITEST anti-HSV 1+2 IgG

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 08594036043695
Basic UDI-DI: B-08594036043695
Reference: OD-369
EMDN: W0105040303
EMDN description: HSV 1+2 IGG
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:45

Manufacturer products View details