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Teco Diagnostics TC-Matrix Uric Acid Reagent Kit U582-1170TM

by Teco Diagnostics

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 Number10673486014075 UDI-DI Date17 Jun 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  • Withdrawn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
Teco Diagnostics TC-Matrix Uric Acid Reagent Kit
Generic Name
Uric acid IVD, reagent
Model / Ref / Catalog
U582-1170TM
Primary DI / UDI-DI
10673486014075
510(k) Number
FDA Product Code
KNK
GMDN Term
Uric acid IVD, reagent
Device Class
Class I
Regulation Number
862.1775
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K914158)

Other devices from Teco Diagnostics

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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