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Tina-quant Albumin Gen.2 09685324190

by Roche Diagnostics Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613336223048 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1124-2019 FDA Class II initiated 14 Dec 2018 on shared 510(k) K101203

    COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Tina-quant Albumin Gen.2
Generic Name
Albumin IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
09685324190
Primary DI / UDI-DI
07613336223048
510(k) Number
FDA Product Code
DCF
GMDN Term
Albumin IVD, kit, nephelometry/turbidimetry
Device Class
Class II
Regulation Number
866.5040
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K101203)

Other devices from Roche Diagnostics Corp.

See all devices from Roche Diagnostics Corp. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No