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40 device results listed.

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Sentosa SA BKV Quantitation Standards (2x13)

300091

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953428
Basic UDI-DI: B-08885013953428
Reference: 300091
EMDN: W0105040522
EMDN description: BK VIRUS - 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 BKV PCR Test (4x24)

300088

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953411
Basic UDI-DI: B-08885013953411
Reference: 300088
EMDN: W0105040522
EMDN description: BK VIRUS - 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

Fluorion

Fluorion BKV QNP 1.0 Real-Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898740508
Basic UDI-DI: B-08698898740508
Reference: M0610202
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 14:59

Manufacturer products View details

LyoSens BKV qPCR Kit

LYO97WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115806093
Basic UDI-DI: B-08685115806093
Reference: LYO97
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:22

Manufacturer products View details

RevoDx BK Virus Quantitative qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215626
Basic UDI-DI: B-08684387215626
Reference: IP202517-100
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:05

Manufacturer products View details

RevoDx BK Virus Quantitative qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215619
Basic UDI-DI: B-08684387215619
Reference: IP202517-25
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:05

Manufacturer products View details

RevoDx BK Virus Quantitative qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214445
Basic UDI-DI: B-08684387214445
Reference: IP202517-100
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:01

Manufacturer products View details

RevoDx BK Virus Quantitative qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214438
Basic UDI-DI: B-08684387214438
Reference: IP202517-25
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:01

Manufacturer products View details

RevoDx BK Virus qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213677
Basic UDI-DI: B-08684387213677
Reference: IP202332-100
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:59

Manufacturer products View details

RevoDx BK Virus qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213660
Basic UDI-DI: B-08684387213660
Reference: IP202332-25
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:59

Manufacturer products View details

TaqPath™ Menu | GeneProof™ BK Virus (BKV) PCR Kit

GeneProof BK Virus (BKV) PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304379
Basic UDI-DI: B-08595696304379
Reference: A58430
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

GeneProof BK Virus (BKV) MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301187
Basic UDI-DI: B-08595696301187
Reference: BKV/MC/205
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:58

Manufacturer products View details

GeneProof BK Virus (BKV) MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301170
Basic UDI-DI: B-08595696301170
Reference: BKV/MC/041
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:58

Manufacturer products View details

Polyomavirus BK (PBK) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229121
Basic UDI-DI: B-06971042229121
Reference: OD-0102-02-A+B
EMDN: W0105040522
EMDN description: BK VIRUS - 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

Polyomavirus BK (PBK) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229114
Basic UDI-DI: B-06971042229114
Reference: OD-0102-02
EMDN: W0105040522
EMDN description: BK VIRUS - 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® BKV HT VER 1.0

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003518
Basic UDI-DI: 40490550300001001TR
Reference: 61596HT
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details

GeneProof BK Virus (BKV) PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161959267
Basic UDI-DI: 859569630027QM
Reference: BKV/GP/100
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

GeneProof BK Virus (BKV) PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161959243
Basic UDI-DI: 859569630027QM
Reference: BKV/GP/025
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

Alinity m

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999050693
Basic UDI-DI: 0884999AMN0985YB
Reference: 09N85-090
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: -
Authorised representative: Abbott GmbH
Last updated: 19.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity m

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999050679
Basic UDI-DI: 0884999AMN0985YB
Reference: 09N85-080
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: -
Authorised representative: Abbott GmbH
Last updated: 19.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details