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cobas® 4800 Cdiff Controls and Cofactor Kit 06768300190

by Roche Molecular Systems, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00875197005288 UDI-DI Date24 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
cobas® 4800 Cdiff Controls and Cofactor Kit
Generic Name
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
06768300190
Primary DI / UDI-DI
00875197005288
FDA Product Code
OOI
GMDN Term
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
Class II
Regulation Number
862.2570
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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