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VIASURE Bordetella Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440213819
Basic UDI-DI: 84354402_MDXRESPB_BDT4F
Reference: VS-BDT196TE
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:37

Manufacturer products View details

VIASURE Bordetella Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440222095
Basic UDI-DI: 84354402_MDXRESPB_BDT4F
Reference: VS-BDT101E
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:37

Manufacturer products View details

VIASURE Bordetella Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440222101
Basic UDI-DI: 84354402_MDXRESPB_BDT4F
Reference: VS-BDT136E
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:37

Manufacturer products View details

VIASURE Bordetella Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440212195
Basic UDI-DI: 84354402_MDXRESPB_BDT4F
Reference: VS-BDT172E
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:37

Manufacturer products View details

D-697994388Fa038WS9D

Bordetella pertussis Nucleic Acid Detection Kit (Fluorescence, Unvaccinated)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Fa038WS9D
Basic UDI-DI: B-697994388Fa038WS9D
Reference: Fa038
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Fa014WC7B

Bordetella pertussis Nucleic Acid Detection Kit (Fluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Fa014WC7B
Basic UDI-DI: B-697994388Fa014WC7B
Reference: Fa014
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

EurobioPlex Bordetella pertussis et parapertussis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-001-UNFK
Basic UDI-DI: B-EBX-001-UNFK
Reference: EBX-001-UN
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 18:27

Manufacturer products View details

EurobioPlex Bordetella pertussis et parapertussis

EurobioPlex Bartonella pertussis et parapertussis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-001-24AT
Basic UDI-DI: B-EBX-001-24AT
Reference: EBX-001-24
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 18:27

Manufacturer products View details

EurobioPlex Bordetella pertussis et parapertussis

EurobioPlex Bartonella pertussis et parapertussis

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-001-48B9
Basic UDI-DI: B-EBX-001-48B9
Reference: EBX-001-48
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 18:27

Manufacturer products View details

Great Basin Bordetella Direct Test

300782

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395GBBordVC
Basic UDI-DI: B-888501395GBBordVC
Reference: 300782
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002ABPTS02JB59

ABPTS02-AHG48E/ ABPTS02-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ABPTS02JB59
Basic UDI-DI: B-81649002ABPTS02JB59
Reference: ABPTS02-AHG48E/ ABPTS02-AHG96E
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens Bordetella pertussis qPCR Kit

LYO52WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115801012
Basic UDI-DI: B-08685115801012
Reference: LYO52
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:22

Manufacturer products View details

RevoDx Bordetella pertussis/parapertussis qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212670
Basic UDI-DI: B-08684387212670
Reference: IP202331-100
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Bordetella pertussis/parapertussis qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212663
Basic UDI-DI: B-08684387212663
Reference: IP202331-25
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Bordetella pertussis qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212656
Basic UDI-DI: B-08684387212656
Reference: IP202330-100
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Bordetella pertussis qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212649
Basic UDI-DI: B-08684387212649
Reference: IP202330-25
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

ChainFor Bordetella pertussis Detection qPCR Kit

CFP80

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257789
Basic UDI-DI: B-08683548257789
Reference: CFP80
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:17

Manufacturer products View details

TaqPath™ Menu | GeneProof™ Bordetella pertussis/parapertussis PCR Kit

GeneProof Bordetella pertussis/parapertussis PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304126
Basic UDI-DI: B-08595696304126
Reference: A58208
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

GeneProof Bordetella pertussis/parapertussis PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161952497
Basic UDI-DI: B-08594161952497
Reference: BP/ISEX/100
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details

GeneProof Bordetella pertussis/parapertussis PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161952473
Basic UDI-DI: B-08594161952473
Reference: BP/ISEX/025
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details