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FLEX Monoclonal Mouse Anti-Human Cytokeratin 5/6, Clone D5/16 B4, Ready-to-Use (Link)

by Agilent Technologies Singapore (International) Pte Ltd

Ref IR78061-2Model IR780

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDD NumberB-SGMF000014448IR78061BX Basic UDI-DI D-SGMF000014448IR78061BXUDI-DIDate24 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
IR780, IR78061-2
Primary DI / UDI-DI
D-SGMF000014448IR78061BX
Basic UDI-DI
B-SGMF000014448IR78061BX
EMDN Code
W0102030126 Cytokeratins
Device Class
Class IVD General
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

  • Reagent
  • Professional Testing

Other properties (9)

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