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One Step LH Ovulation Rapid Test Dipstick 1

by Hangzhou AllTest Biotech Co., Ltd. 3 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06942598202357 UDI-DIDate10 Oct 2025ListedStatusListed 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  • Withdrawn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
One Step LH Ovulation Rapid Test Dipstick
Generic Name
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Model / Reference
1
Primary DI / UDI-DI
06942598202357
FDA Product Code
NGE
GMDN Term
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Device Class
Class I
Regulation Number
862.1485
GUDID distribution status
In Commercial Distribution

Other devices from Hangzhou Alltest Biotech.Co., Ltd.

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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