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TTV R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026611309
Basic UDI-DI: 357302BUDI000864UC
Reference: 423414
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:58

Manufacturer products View details

VIDAS® Anti-CHIKUNGUNYA IgG

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026610357
Basic UDI-DI: 357302BUDI000921TX
Reference: 423230
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:58

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VIDAS® Anti-CHIKUNGUNYA IgM

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026610340
Basic UDI-DI: 357302BUDI000920TV
Reference: 423229
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:58

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VIDAS® DENGUE NS1 Ag

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608217
Basic UDI-DI: 357302BUDI000852U5
Reference: 423077
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

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VZV R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026602017
Basic UDI-DI: 357302BUDI000597UC
Reference: 71-022
EMDN: W0105040904
EMDN description: VARICELLA ZOSTER - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:55

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HSV1 HSV2 R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026602000
Basic UDI-DI: 357302BUDI000596UA
Reference: 71-021
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:55

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HHV6 R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026564001
Basic UDI-DI: 357302BUDI000598UE
Reference: 69-006B
EMDN: W0105040524
EMDN description: HHV-6,7,8 - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:53

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VIDAS® CMV IgG Avidity II

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026402969
Basic UDI-DI: 357302BUDI000346TH
Reference: 413557
EMDN: W0105040206
EMDN description: CMV IGG - AVIDITY
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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Parechovirus R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026387969
Basic UDI-DI: 357302BUDI000554TS
Reference: 71-020
EMDN: W0105040521
EMDN description: PARECHOVIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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BK Virus R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026387761
Basic UDI-DI: 357302BUDI000441TC
Reference: 69-013B
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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ADENOVIRUS R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026387723
Basic UDI-DI: 357302BUDI000440TA
Reference: 69-010B
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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ENTEROVIRUS R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026387709
Basic UDI-DI: 357302BUDI000551TL
Reference: 69-005B
EMDN: W0105040502
EMDN description: ENTEROVIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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EBV R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026387648
Basic UDI-DI: 357302BUDI000198TS
Reference: 69-002B
EMDN: W0105040403
EMDN description: EBV - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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Parvovirus B19 R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026383190
Basic UDI-DI: 357302BUDI000442TE
Reference: 69-019B
EMDN: W0105040509
EMDN description: PARVOVIRUS B 19 - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

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VIDAS® EBV VCA/EA IgG

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064617
Basic UDI-DI: 357302BUDI000080T2
Reference: 30236
EMDN: W010504040105
EMDN description: EBV VCA IGG
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

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VIDAS® EBV EBNA IgG

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064600
Basic UDI-DI: 357302BUDI000079TH
Reference: 30235
EMDN: W010504040106
EMDN description: EBV EBNA IGG
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

VIDAS® EBV VCA IgM

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064624
Basic UDI-DI: 357302BUDI000081T4
Reference: 30237
EMDN: W010504040104
EMDN description: EBV VCA IGM
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

VIDAS® RUB IgG II

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064556
Basic UDI-DI: 357302BUDI000077TD
Reference: 30221
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

VIDAS® CMV IgG

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064389
Basic UDI-DI: 357302BUDI000590TW
Reference: 30204
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:47

Manufacturer products View details

HSV 2 IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISGMB-402DD
Basic UDI-DI: B-ISGMB-402DD
Reference: ISGMB-402
EMDN: W0105040308
EMDN description: HSV 2 ANTIBODIES - TOTAL
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details