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Gentian Cystatin C Reagent Kit for the Beckman Coulter AU Systems

by Gentian AS

Ref 1103 / B08179Model 1101

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number9003846B01CYSC001QC Basic UDI-DI 17090038460013UDI-DIDate21 Oct 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number17090038460013 UDI-DI Date24 Sep 2016ListedStatusListed 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.

Recalls

1 recall · FDA

    • Terminated Z-0099-2021 FDA Class II initiated 2 Sep 2020

    The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.

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  • Withdrawn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
Gentian Cystatin C Reagent Kit for the Beckman Coulter AU Systems EUDAMED
Gentian Cystatin C Reagent for the Beckman Coulter AU Systems (1x300) GUDID
Generic Name
Cystatin C IVD, kit, nephelometry/turbidimetry
Device Name
Gentian Cystatin C Reagent Kit
Model / Reference
1101, 1103 / B08179
Primary DI / UDI-DI
17090038460013
Basic UDI-DI
9003846B01CYSC001QC
510(k) Number
FDA Product Code
NDY
EMDN Code
W0102019008 Cystatin c
GMDN Term
Cystatin C IVD, kit, nephelometry/turbidimetry
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.1225
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Manufacturer details

EUDAMED SRN
NO-MF-000003448

Other devices from Gentian AS

See all devices from Gentian AS →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Convenience Kit
  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No