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FERTICARE Strip

by Weihai Kangzhou Biotechnology Engineering Co., Ltd 3 variants

FERTICARE Strip is a Class I device made by Weihai Kangzhou Biotechnology Engineering Co., Ltd, listed in FDA GUDID since 11 Jan 2024 (UDI-DI 06923304611120), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06923304611120 UDI-DI Date11 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Ferticare
Generic name
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Model / reference
Strip
Primary DI / UDI-DI
06923304611120
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

Similar devices

Other devices filed under FDA product code NGE (Test, Luteinizing Hormone (Lh), Over The Counter).

Other devices from Weihai Kangzhou Biotechnology Engineering Co., Ltd

  • Ferticare Strip

    Class II
  • FERTICARE midstream

    Class II
  • NuValu cassette

    Class II
  • NuValu Midstream

    Class II

See all devices from Weihai Kangzhou Biotechnology Engineering Co., Ltd →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)