Skip to content

Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test P597-25

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 Number10673486014020 UDI-DI Date9 Apr 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  • Withdrawn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 One-Step Urine/Serum Combo Pregnancy Dipstick Test
Generic Name
Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
P597-25
Primary DI / UDI-DI
10673486014020
510(k) Number
FDA Product Code
JHI
GMDN Term
Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.1155
GUDID distribution status
In Commercial Distribution

Other devices from Teco Diagnostics

See all devices from Teco Diagnostics →

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