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FLEX Mono Mo A-Hu Smooth Muscle Actin, Cl 1A4, RTU (Dako Omnis) GA611

by Agilent Technologies Singapore Pte Ltd

Ref GA61161-2Model GA611, GA611/IR611

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED NumberB-SGMF000014448GA6116129 Basic UDI-DI Date24 Aug 2026RegisteredStatusActive
European UnionCE/IVDD EUDAMED NumberB-SGMF000014448GA6116129 Basic UDI-DI Date24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05700572033301 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  • Withdrawn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 Monoclonal Mouse Anti-Human Smooth Muscle Actin, Clone 1A4, Ready-to-Use (Dako Omnis) EUDAMED
FLEX Mono Mo A-Hu Smooth Muscle Actin, Cl 1A4, RTU (Dako Omnis) GUDID
Generic Name
Smooth muscle actin IVD, antibody
Model / Reference
GA611, GA61161-2, GA611/IR611
Primary DI / UDI-DI
05700572033301, D-SGMF000014448GA6116129
Basic UDI-DI
B-SGMF000014448GA6116129, 570057R0301P3007C005401MF
FDA Product Code
NJT
EMDN Code
W0102030199 Cancer antigens - other
GMDN Term
Smooth muscle actin 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: Smooth muscle actin 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