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Dako GA072

by Agilent Technologies, Inc.

Ref GA07261-2Model GA072

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05700571106785 UDI-DI Date8 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number570057R0301P3007C071701PF Basic UDI-DI 05700571106785UDI-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  • Withdrawn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 Mouse Anti-Human Podoplanin, Clone D2-40, Ready-to-Use (Dako Omnis) EUDAMED
Dako GUDID
Generic Name
D2-40 antigen IVD, antibody
Model / Reference
GA072, GA07261-2
Primary DI / UDI-DI
05700571106785
Basic UDI-DI
570057R0301P3007C071701PF
FDA Product Code
NJT
EMDN Code
W0102030199 Cancer antigens - other
GMDN Term
D2-40 antigen 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

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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