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Teco Diagnostics H. Pylori Card Test H730-50

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 Number10673486013986 UDI-DI Date27 Jan 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  • Withdrawn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 H. Pylori Card Test
Generic Name
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
H730-50
Primary DI / UDI-DI
10673486013986
510(k) Number
FDA Product Code
LYR
GMDN Term
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical
Device Class
Class I
Regulation Number
866.3110
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K024360)

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