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FLEX Monoclonal Rabbit Anti-Human Terminal Deoxynucleotidyl Transferase, Clone EP266, Ready-to-Use (Dako Omnis)

by Agilent Technologies, Inc.

Ref GA09361-2Model GA093

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05700575011023 UDI-DI Date8 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number570057R0301P3007C072301P2 Basic UDI-DI 05700575011023UDI-DIDate4 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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
FLEX Monoclonal Rabbit Anti-Human Terminal Deoxynucleotidyl Transferase, Clone EP266, Ready-to-Use (Dako Omnis) EUDAMED
Dako GUDID
Generic Name
Terminal deoxynucleotidyl transferase (TdT) IVD, antibody
Model / Reference
GA093, GA09361-2
Primary DI / UDI-DI
05700575011023
Basic UDI-DI
570057R0301P3007C072301P2
FDA Product Code
NJT
EMDN Code
W0102030199 Cancer antigens - other
GMDN Term
Terminal deoxynucleotidyl transferase (TdT) IVD, antibody
Device Class
Class C EUDAMED
Class I GUDID
Regulation Number
864.1860
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 12 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000009385
Authorised representative
Agilent Technologies Denmark ApS DK-AR-000001443

Other devices from Agilent Technologies, Inc.

See all devices from Agilent Technologies, Inc. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No