Skip to content

FLEX Poly Rb A-Hu IgG, RTU (Dako Omnis) GA512

by Agilent Technologies Singapore Pte Ltd

Ref GA51261-2Model GA512, GA512/A0424

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

CE IVDR CE IVDD

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
European UnionCE/IVDR EUDAMED NumberB-SGMF000014448GA5126123 Basic UDI-DI Date24 Aug 2026RegisteredStatusActive
European UnionCE/IVDD EUDAMED NumberB-SGMF000014448GA5126123 Basic UDI-DI Date24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05700572034100 UDI-DI Date17 Sep 2020ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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, CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
FLEX Polyclonal Rabbit Anti-Human IgG, Ready-to-Use (Dako Omnis) EUDAMED
FLEX Poly Rb A-Hu IgG, RTU (Dako Omnis) GUDID
Generic Name
Total immunoglobulin G (IgG total) IVD, antibody
Device Name
FLEX Polyclonal Rabbit Anti-Human IgG, Ready-to-Use
Model / Reference
GA512, GA51261-2, GA512/A0424
Primary DI / UDI-DI
05700572034100, D-SGMF000014448GA5126123
Basic UDI-DI
B-SGMF000014448GA5126123, 570057R0301P3007C013901N5
FDA Product Code
NJT
EMDN Code
W0102030199 Cancer antigens - other
GMDN Term
Total immunoglobulin G (IgG total) IVD, antibody
Device Class
Class IVD General EUDAMED
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 IVD General
Class C
GUDID
Class I

Related devices

Category: Total immunoglobulin G (IgG total) IVD, antibody

Other devices from Agilent Technologies Singapore Pte Ltd

See all devices from Agilent Technologies Singapore Pte Ltd →

Properties

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

Other properties (18)

  • 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
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No