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FLEX Monoclonal Mouse Anti-Cytomegalovirus, Clone CCH2 + DDG9, Ready-to-Use (Dako Omnis)

by Agilent Technologies Singapore (International) Pte Ltd

Ref GA75261-2Model GA752, GA752/IR752

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-SGMF000014448GA752613M Basic UDI-DI Date24 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-SGMF000014448GA752613M Basic UDI-DI Date24 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Device Name
FLEX Monoclonal Mouse Anti-Cytomegalovirus, Clone CCH2 + DDG9, Ready-to-Use
Model / Reference
GA752, GA75261-2, GA752/IR752
Primary DI / UDI-DI
D-SGMF000014448GA752613M, 05700572034360
Basic UDI-DI
B-SGMF000014448GA752613M, 570057GA752RTUK6
EMDN Code
W0105040201 Cmv antigen
Device Class
Class IVD Annex II List B
Class C
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
SG-MF-000014448
Authorised representative
Agilent Technologies Denmark ApS DK-AR-000001443

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Properties

  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No