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Urea/BUN 09686363190

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 Number07613336223284 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0688-2008 FDA Unclassified (pre-2012) initiated 3 Dec 2007 on shared 510(k) K972250

    False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers.

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  • Withdrawn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
Urea/BUN
Generic Name
Urea IVD, kit, spectrophotometry
Model / Ref / Catalog
09686363190
Primary DI / UDI-DI
07613336223284
510(k) Number
FDA Product Code
CDQ
GMDN Term
Urea IVD, kit, spectrophotometry
Device Class
Class II
Regulation Number
862.1770
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K972250)

Show all (12)

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