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FLEX Poly Rb A-Hu Lambda LC RTU (Dako Omnis) GA507

by Agilent Technologies Singapore Pte Ltd United States EUDAMEDGUDID

Ref GA50761-2Model GA507, GA507/IR507/Q0499

Product code NJTEMDN W0102010109

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED NumberB-SGMF000014448GA507612M Basic UDI-DIDate24 Aug 2026RegisteredStatusActive
European UnionCE/IVDD EUDAMED NumberB-SGMF000014448GA507612M Basic UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05700572033257 UDI-DIDate17 Sep 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR, CE/IVDD Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
FLEX Polyclonal Rabbit Anti-Human Lambda Light Chains, Ready-to-Use (Dako Omnis) EUDAMED
FLEX Poly Rb A-Hu Lambda LC RTU (Dako Omnis) GUDID
Generic Name
Kappa/lambda light chain immunoglobulin IVD, antibody
Model / Reference
GA507, GA50761-2, GA507/IR507/Q0499
Primary DI / UDI-DI
05700572033257, D-SGMF000014448GA507612M
Basic UDI-DI
B-SGMF000014448GA507612M, 570057R0301P3007C013401MC
FDA Product Code
NJT
EMDN Code
W0102010109 Kappa and lambda chain
GMDN Term
Kappa/lambda light chain immunoglobulin IVD, antibody
Device Class
Class IVD General EUDAMED
Class C EUDAMED
Class I GUDID
Regulation Number
864.1860
Market of Registration
Denmark
Commercial Distribution
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: Kappa/lambda light chain immunoglobulin IVD, antibody

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (3)

  • FDA UDI 0d34a46c-e9ea-43f1-bc88-6a75c543bce1 36 fields · synced 24 Oct 2026
  • EUDAMED D-SGMF000014448GA507612M|B-SGMF000014448GA507612M 61 fields · synced 8 Oct 2026
  • EUDAMED 05700572033257|570057R0301P3007C013401MC 61 fields · synced 24 Oct 2026