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TTF-1 & Cytokeratin 5 Multiplex Cocktail; Clones 8G7G3/1 & EP42 (Ready-To-Use) 7 mL

by ScyTek Laboratories Inc.

Ref A00145-0007

Active European Union

CE IVDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081010871W01030709FJ Basic UDI-DI 00810108712220UDI-DIDate7 Dec 2022RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Primary Antisera for Immunohistology
Model / Reference
A00145-0007
Primary DI / UDI-DI
00810108712220
Basic UDI-DI
081010871W01030709FJ
Direct Marketing DI
00810108712220
EMDN Code
W01030709 Primary antisera for immunohistology
Models / Variants
Device Class
Class C
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000023816
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Animal Tissues
  • 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