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Gentian Cystatin C Single Use Control Low 1029

by Gentian AS Norway GUDID

Product code NDY

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07090038460115 UDI-DIDate18 Nov 2016ListedStatusWithdrawn

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

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.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Gentian Cystatin C Single Use Control Low
Generic Name
Cystatin C IVD, control
Model / Reference
1029
Primary DI / UDI-DI
07090038460115
510(k) Number
FDA Product Code
NDY
GMDN Term
Cystatin C IVD, control
Device Class
Class II
Regulation Number
862.1225
Commercial Distribution
Not in Commercial Distribution

Other devices from Gentian AS

See all devices from Gentian AS →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 2bfcbd05-afa0-4a4e-bcc8-3cf6414cc125 35 fields · synced 23 Oct 2026