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FLEX Poly Rb A-Hu Calcitonin RTU (Dako Omnis) GA515

by Agilent Technologies Singapore Pte Ltd EUDAMEDGUDID

Active European Union and United States

Ref GA51561-2Model GA515

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED NumberB-SGMF000014448GA515612J Basic UDI-DIDate24 Aug 2026RegisteredStatusActive
European UnionCE/IVDD EUDAMED NumberB-SGMF000014448GA515612J Basic UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05700572034124 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 AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR, CE/IVDD Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name
FLEX Polyclonal Rabbit Anti-Human Calcitonin, Ready-to-Use (Dako Omnis) EUDAMED
FLEX Poly Rb A-Hu Calcitonin RTU (Dako Omnis) GUDID
Generic Name
Calcitonin IVD, antibody
Model / Reference
GA515, GA51561-2
Primary DI / UDI-DI
05700572034124, D-SGMF000014448GA515612J
Basic UDI-DI
B-SGMF000014448GA515612J, 570057R0301P3007C014401MK
FDA Product Code
NJT
EMDN Code
W0102030199 Cancer antigens - other
GMDN Term
Calcitonin 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: Calcitonin IVD, antibody

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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