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PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit

PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056362037
Basic UDI-DI: B-08800056362037
Reference: R6200T
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

PowerChek™ Influenza B (Victoria & Yamagata) Real-time PCR Kit Ver.1.1

PowerChek™ Influenza B (Victoria & Yamagata) Real-time PCR Kit Ver.1.1

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056330005
Basic UDI-DI: B-08800056330005
Reference: R3013TA
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

PowerChek™ Norovirus GI / GII Multiplex Real-time PCR Kit

PowerChek™ Norovirus GI / GII Multiplex Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056302002
Basic UDI-DI: B-08800056302002
Reference: R0210E
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

QMCOVID02

IVD generalIVDDNo longer on the marketKitProfessional testingReagent

Manufacturer: QuantaMatrix Inc.
Manufacturer SRN: KR-MF-000022784
UDI-DI: 08800044300089
Basic UDI-DI: B-08800044300089
Reference: QMCOVID02
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: -
Authorised representative: KTR Europe GmbH
Last updated: 10.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

RealAccurate® Quadruplex SARS-CoV-2 PCR Kit

PF0971C-R

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoFinder B.V.
Manufacturer SRN: NL-MF-000002704
UDI-DI: 08719327497906
Basic UDI-DI: B-08719327497906
Reference: PF0971C-R
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.07.2026 19:05

Manufacturer products View details

RespiFinder® 2SMART

PF2600-2S

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoFinder B.V.
Manufacturer SRN: NL-MF-000002704
UDI-DI: 08719327116197
Basic UDI-DI: B-08719327116197
Reference: PF2600-2S
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.07.2026 19:05

Manufacturer products View details

Fluorion nCoV-19 QLP 2.2 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: 08698898741796
Basic UDI-DI: B-08698898741796
Reference: M1490102-5
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

Fluorion RSV QLP 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: 08698898741024
Basic UDI-DI: B-08698898741024
Reference: M1400102
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

Fluorion Rhinovirus QLP 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: 08698898741017
Basic UDI-DI: B-08698898741017
Reference: M1420102
EMDN: W0105040520
EMDN description: RHINOVIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

Fluorion Influenza A/B QLP 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: 08698898740973
Basic UDI-DI: B-08698898740973
Reference: M1410102
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

Fluorion nCoV-19 QLP 2.1 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: 08698898740935
Basic UDI-DI: B-08698898740935
Reference: M1350102
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

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 FLU B qPCR Kit

LYO147WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115808219
Basic UDI-DI: B-08685115808219
Reference: LYO147
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:23

Manufacturer products View details

LyoSens FLU A qPCR Kit

LYO146WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115808097
Basic UDI-DI: B-08685115808097
Reference: LYO146
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:23

Manufacturer products View details

LyoSens RSV A + B qPCR Kit

LYO148WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115808332
Basic UDI-DI: B-08685115808332
Reference: LYO148
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:23

Manufacturer products View details

LyoSens JCV qPCR Kit

LYO100WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115807755
Basic UDI-DI: B-08685115807755
Reference: LYO100
EMDN: W0105040523
EMDN description: JC VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:23

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

LyoSens ADV Quantitative qPCR Kit

LYO130WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805126
Basic UDI-DI: B-08685115805126
Reference: LYO130
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:22

Manufacturer products View details

LyoSens Influenza A qPCR Kit

LYO113WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277594
Basic UDI-DI: B-08684998277594
Reference: LYO113
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:21

Manufacturer products View details

LyoSens FLU A + B qPCR Kit

LYO37WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998274616
Basic UDI-DI: B-08684998274616
Reference: LYO37
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:21

Manufacturer products View details