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Albumin Gen.2 10653752190

by Roche Diagnostics Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 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 Number07613336245286 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

    • Terminated Z-0104-2021 FDA Class III initiated 27 Aug 2020

    Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

    • Terminated Z-0152-2020 FDA Class III initiated 11 Sep 2019

    Due to low Quality Control recovery and invalid Calibration.

    • Terminated Z-0011-2009 FDA Unclassified (pre-2012) initiated 11 Jun 2008

    Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Albumin Gen.2
Generic Name
Albumin IVD, kit, spectrophotometry
Model / Ref / Catalog
10653752190
Primary DI / UDI-DI
07613336245286
510(k) Number
FDA Product Code
CIX
GMDN Term
Albumin IVD, kit, spectrophotometry
Device Class
Class II
Regulation Number
862.1035
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K033009)

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