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KOVA-Trol III Normal with hCG 87331

by LGC Clinical Diagnostics, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850075957385 UDI-DI Date17 Apr 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  • Withdrawn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
KOVA-Trol III Normal with hCG
Generic Name
Urine sediment IVD, control
Model / Reference
87331
Primary DI / UDI-DI
00850075957385
FDA Product Code
JJY
GMDN Term
Urine sediment IVD, control
Device Class
Class I
Regulation Number
862.1660
GUDID distribution status
In Commercial Distribution

Other devices from LGC Clinical Diagnostics, Inc.

See all devices from LGC Clinical Diagnostics, Inc. →

Properties

  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No