Skip to content

One Step® HCG Early Rapid Pregnancy Strips 15T

by Guangzhou Decheng Biotechnology Co., LTD

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number06974464591340 UDI-DI Date31 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
One Step® HCG Early Rapid Pregnancy Strips
Generic Name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Model / Reference
15T
Primary DI / UDI-DI
06974464591340
510(k) Number
FDA Product Code
LCX
GMDN Term
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
862.1155
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K240643)

Show all (10)

Other devices from Guangzhou Decheng Biotechnology Co., Ltd.

See all devices from Guangzhou Decheng Biotechnology Co., Ltd. →

Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No