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129 device results listed.

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VIASURE Clostridium difficile toxins A+B 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: 08435440228509
Basic UDI-DI: 84354402_MDXGASTROB_CDAP6
Reference: VS-CDA113LE
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

VIASURE Clostridium difficile toxins A+B 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: 08435440228462
Basic UDI-DI: 84354402_MDXGASTROB_CDAP6
Reference: VS-CDA113HE
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

VIASURE Clostridium difficile toxins A+B 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: 08435440223382
Basic UDI-DI: 84354402_MDXGASTROB_CDAP6
Reference: VS-CDA196TE
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

01220000260054

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260054
Basic UDI-DI: 122000026NATERCK5
Reference: NATCDI-6MC-IVD
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:15

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® C. difficile BT

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002299
Basic UDI-DI: B-07332940002299
Reference: GXCDIFFBT-CE-10
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® C.difficile

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940000011
Basic UDI-DI: B-07332940000011
Reference: GXCDIFFICILE-CE-10
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

04099466110732

Serazym® Clostridium difficile GDH

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466110732
Basic UDI-DI: B-04099466110732
Reference: E-107
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

04099466104038

Serazym® Clostridium difficile Toxin A+B

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466104038
Basic UDI-DI: B-04099466104038
Reference: E-040
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

Clostridium botulinum Real Time PCR Kit

YJB20130NW-50T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJB20130NW-50TVV
Basic UDI-DI: B-YJB20130NW-50TVV
Reference: YJB20130NW-50T
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 14:02

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium botulinum Real Time PCR Kit

YJB20130NW-25T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJB20130NW-25TVV
Basic UDI-DI: B-YJB20130NW-25TVV
Reference: YJB20130NW-25T
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 14:02

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridioides difficile Real Time PCR Kit

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB10130NW-50TMH
Basic UDI-DI: B-JB10130NW-50TMH
Reference: JB10130NW-50T
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridioides difficile Real Time PCR Ki

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB10130NW-25TMH
Basic UDI-DI: B-JB10130NW-25TMH
Reference: JB10130NW-25T
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces)

GCCD-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCD-602aRS
Basic UDI-DI: B-GCCD-602aRS
Reference: GCCD-602a
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile Toxin A&B Rapid Test Casette (Feces)

GCCD(Toxin A/B)-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCD(ToxinAB)-602aZC
Basic UDI-DI: B-GCCD(ToxinAB)-602aZC
Reference: GCCD(Toxin A/B)-602a
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile Antigen GDH Rapid Test Cassette (Feces)

GCCD(GDH)-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCD(GDH)-602aH3
Basic UDI-DI: B-GCCD(GDH)-602aH3
Reference: GCCD(GDH)-602a
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

GenomEra C. difficile Assay Kit

CDX-40

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-40-02-40UPG
Basic UDI-DI: B-CDX-40-02-40UPG
Reference: CDX-40-02-40
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® C. difficile Assay Kit

CDX-40

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-40-02-40UC
Basic UDI-DI: B-CDX-40-02-40UC
Reference: CDX-40-02-40
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® C. difficile Assay Kit

CDX-40

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-40-01-40UP5
Basic UDI-DI: B-CDX-40-01-40UP5
Reference: CDX-40-01-40
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® C. difficile Assay Kit

CDX-40

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-40-01-40U5
Basic UDI-DI: B-CDX-40-01-40U5
Reference: CDX-40-01-40
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra C. difficile Assay Kit

CDX-40

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-40-01-20UNT
Basic UDI-DI: B-CDX-40-01-20UNT
Reference: CDX-40-01-20
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details