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cobas BV/CV Control Kit 09988807190

by Roche Molecular Systems, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00875197007480 UDI-DI Date28 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
cobas BV/CV Control Kit
Generic Name
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
Model / Ref / Catalog
09988807190
Primary DI / UDI-DI
00875197007480
510(k) Number
FDA Product Code
PQA
GMDN Term
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
Device Class
Class II
Regulation Number
866.3975
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K260021)

Other devices from Roche Molecular System, Inc.

See all devices from Roche Molecular System, Inc. →

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