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Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set ASO-50

by Teco Diagnostics

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 Number10673486014051 UDI-DI Date7 May 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  • Withdrawn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
Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set
Generic Name
Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD, kit, rapid agglutination, clinical
Model / Ref / Catalog
ASO-50
Primary DI / UDI-DI
10673486014051
FDA Product Code
GTQ
GMDN Term
Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD, kit, rapid agglutination, clinical
Device Class
Class I
Regulation Number
866.3720
GUDID distribution status
In Commercial Distribution

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Properties

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

Other properties (9)

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