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702 device results listed.

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Optitrol NAT HCV Screening

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670927
Basic UDI-DI: 426046567NTHCVScrD8
Reference: NT01021
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:41

Manufacturer products View details

Optitrol NAT HBV Viral Load

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670903
Basic UDI-DI: 426046567NTHBVVLSQ
Reference: NT01013
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:41

Manufacturer products View details

Optitrol NAT HBV Screening

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670880
Basic UDI-DI: 426046567NTHBVScrCV
Reference: NT01011
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:41

Manufacturer products View details

Optitrol HIV 2

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670545
Basic UDI-DI: 426046567SRHIV2HT
Reference: SR11113
EMDN: W0105080803
EMDN description: RETROVIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:41

Manufacturer products View details

Optitrol HIVp24

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670507
Basic UDI-DI: 426046567SRHIVp24DE
Reference: SR11101
EMDN: W0105080803
EMDN description: RETROVIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:41

Manufacturer products View details

Optitrol HEPA-1

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670460
Basic UDI-DI: 426046567SRHEPAHH
Reference: SR12025
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:41

Manufacturer products View details

Optitrol HEPR-1

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670422
Basic UDI-DI: 426046567SRHEPRJK
Reference: SR12045
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:41

Manufacturer products View details

Optitrol SeroNeg

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670378
Basic UDI-DI: 426046567SRSeroNegZ5
Reference: SR11000
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:40

Manufacturer products View details

Optitrol Orange

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670316
Basic UDI-DI: 426046567SROrange4T
Reference: SR11061
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:40

Manufacturer products View details

Optitrol Red

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670286
Basic UDI-DI: 426046567SRRedKT
Reference: SR11051
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:40

Manufacturer products View details

Optitrol Green

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670255
Basic UDI-DI: 426046567SRGreenA2
Reference: SR11041
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:40

Manufacturer products View details

Optitrol Yellow

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670194
Basic UDI-DI: 426046567SRYellow8D
Reference: SR11021
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:40

Manufacturer products View details

Optitrol Blue

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaMex GmbH
Manufacturer SRN: DE-MF-000037219
UDI-DI: 4260465670163
Basic UDI-DI: 426046567SRBlueSF
Reference: SR11011
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:40

Manufacturer products View details

04049095210037

RIDA®UNITY Internal Control Kit

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210037
Basic UDI-DI: 4049095UN00100000KZ
Reference: UN0010
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

Universal Internal Control 2 VER 1.0

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003686
Basic UDI-DI: 40490550300001067UP
Reference: 402960
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

NatQal HCV

NatQal HCV - HIV - HBV - HEV

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN: FR-MF-000013221
UDI-DI: 03760369292115
Basic UDI-DI: 376036929DGV0019K
Reference: 190000
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:43

Manufacturer products View details

SeroQal COB 6

SeroQal

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN: FR-MF-000013221
UDI-DI: 03760369291194
Basic UDI-DI: 376036929SMI001EV
Reference: 270429
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:43

Manufacturer products View details

Access anti-HAV IgM QC

C39449

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745141
Basic UDI-DI: 150995901C39449SG
Reference: C39449
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Access anti-HAV QC

C39446

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745110
Basic UDI-DI: 150995901C39446SA
Reference: C39446
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Internal Control-X

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510470
Basic UDI-DI: 54200455DIAGPFINTCTRLWV
Reference: PRD-04476
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: Hologic BV
Last updated: 30.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details