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One Step® LH Ovulation Rapid Test Dipstick (Urine) 15T

by Guangzhou Decheng Biotechnology Co., LTD GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841695111585 UDI-DIDate3 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
One Step® LH Ovulation Rapid Test Dipstick (Urine)
Generic Name
Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Model / Reference
15T
Primary DI / UDI-DI
00841695111585
FDA Product Code
NGE
GMDN Term
Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Device Class
Class I
Regulation Number
862.1485
GUDID distribution status
In Commercial Distribution

Other devices from Guangzhou Decheng Biotechnology Co., Ltd.

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

Properties

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

Other properties (9)

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