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Creatinine plus ver.2 09686240190

by Roche Diagnostics Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 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 Number07613336223192 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-1125-2019 FDA Class II initiated 14 Dec 2018 on shared 510(k) K024098

    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

    • Terminated Z-0008-2009 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.

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  • Withdrawn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
Creatinine plus ver.2
Generic Name
Creatinine IVD, kit, spectrophotometry
Model / Ref / Catalog
09686240190
Primary DI / UDI-DI
07613336223192
510(k) Number
FDA Product Code
JFY
GMDN Term
Creatinine IVD, kit, spectrophotometry
Device Class
Class II
Regulation Number
862.1225
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K024098)

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