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138 device results listed.

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LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214524270
Basic UDI-DI: 868521452PCR157GH
Reference: LYO157WS48
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214524317
Basic UDI-DI: 868521452PCR157GH
Reference: LYO157WS96
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525772
Basic UDI-DI: 868521452PCR157GH
Reference: CFP157P25
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525789
Basic UDI-DI: 868521452PCR157GH
Reference: CFP157P50
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525796
Basic UDI-DI: 868521452PCR157GH
Reference: CFP157P100
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

BioFire® Blood Culture Identification 2 (BCID2) Panel

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020338
Basic UDI-DI: 357302BUDI000001SC
Reference: RFIT-ASY-0147
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Nc010ZABW

Shigella/Entamoeba histolytica Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Nc010ZABW
Basic UDI-DI: B-697994388Nc010ZABW
Reference: Nc010
EMDN: W0105070201
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Fa010W45T

Shigella/Entamoeba histolytica 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-697994388Fa010W45T
Basic UDI-DI: B-697994388Fa010W45T
Reference: Fa010
EMDN: W0105070201
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX 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

Sepsis-Q Real Time PCR Kit

G2M804026,G2M804026R

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M804026FE
Basic UDI-DI: B-G2M804026FE
Reference: G2M804026,G2M804026
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria Gonorrhoeae Antigen Rapid Test Kit(Colloidal gold method)