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P0247 ViraQ WNV Check 125

IVD Class BIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingSingle use

Manufacturer: Biologicals Quality Control B.V.
Manufacturer SRN: NL-MF-000026798
UDI-DI: 08718719830406
Basic UDI-DI: 871871983P0247EX
Reference: P0247/03
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Netherlands
Authorised representative: -
Last updated: 24.09.2026 01:33

Manufacturer products View details

P0318 ViraQ HIV-2 Check 125

IVD Class BIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingSingle use

Manufacturer: Biologicals Quality Control B.V.
Manufacturer SRN: NL-MF-000026798
UDI-DI: 08718719830307
Basic UDI-DI: 871871983P0318EV
Reference: P0318/02
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Netherlands
Authorised representative: -
Last updated: 24.09.2026 01:32

Manufacturer products View details

ChainFor™

Neisseria meningitidis Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277341
Basic UDI-DI: 868499827PCR113YH
Reference: CFP113P50
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:25

Manufacturer products View details

ChainFor™

H.pylori/Clarithromycin Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276405
Basic UDI-DI: 868511580PCR144GP
Reference: CFP144P50
EMDN: W0105050399
EMDN description: OTHER PARASITOLOGY - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:25

Manufacturer products View details

LyoSens™

CMV Quantitative qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275095
Basic UDI-DI: 868499827PCR109YS
Reference: LYO109WS24
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:25

Manufacturer products View details

RapidFor™

SARS-CoV-2 + FLU A/B + RSV + ADV Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998274296
Basic UDI-DI: 868354825VMD79SC4C
Reference: VMD79BC01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:25

Manufacturer products View details

ChainFor™

Respiratory v1.0 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595036747
Basic UDI-DI: 868511580PCR101G5
Reference: CFP101P25
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:24

Manufacturer products View details

ChainFor™

Strep B qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034576
Basic UDI-DI: 868511580PCR111G8
Reference: CFP111P25
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:24

Manufacturer products View details

RapidFor™

Syphilis Ab Test Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595036600
Basic UDI-DI: 868334794VMD04BDZM
Reference: VMD04BD50
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:24

Manufacturer products View details

ChainFor™

Dengue/Chikungunya/Zika Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595033968
Basic UDI-DI: 868511580PCR92JR
Reference: CFP92P50
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:24

Manufacturer products View details

ChainFor™

Malaria qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032091
Basic UDI-DI: 868499827PCR69YD
Reference: CFP69P25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:24

Manufacturer products View details

ChainFor™

Candida auris qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032077
Basic UDI-DI: 868499827PCR68YB
Reference: CFP68P25
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:23

Manufacturer products View details

ChainFor™

LYO04WS24

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031414
Basic UDI-DI: 868354825PCR04NH
Reference: CFP04P25
EMDN: W0105011003
EMDN description: SALMONELLA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:23

Manufacturer products View details

ChainFor™

Respiratory v2.0 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259776
Basic UDI-DI: 868511580PCR102G7
Reference: CFP102P25
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:23

Manufacturer products View details

LyoSens™

Lyme Disease qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259073
Basic UDI-DI: 868511580PCR67JS
Reference: LYO67WS24
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:23

Manufacturer products View details

LyoSens™

HSV-1/HSV-2/VZV Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259035
Basic UDI-DI: 868511580PCR61JE
Reference: LYO61WS24
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:23

Manufacturer products View details

SARS-CoV-2 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-COVID-502bA5
Basic UDI-DI: B-COVID-502bA5
Reference: COVID-502b
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Spain
Authorised representative: Llins Service & Consulting GmbH
Last updated: 24.09.2026 00:56

Manufacturer products Authorised representative products Authorised representative actors View details

recomBlot, recomLine Substrate TMB prec.

Dyeing solutions

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125640
Basic UDI-DI: 42505711B2102WJ
Reference: 10068
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 23:52

Manufacturer products View details

recomLine, recomBlot Anti-human IgG conjugate

Conjugates

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125596
Basic UDI-DI: 42505711B2101WG
Reference: 10064
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 23:16

Manufacturer products View details

recomBlot, recomLine Wash buffer A 10x

Buffer solutions

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125541
Basic UDI-DI: 42505711B2100WE
Reference: 10061
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 23:16

Manufacturer products View details