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SURESIGN™ Menopause (FSH) Rapid Test 01005-5

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 Number00045611010055 UDI-DIDate28 Jan 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  • Withdrawn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 23 Oct 2026.

Specification

GUDID

Trade Name
SURESIGN™ Menopause (FSH) Rapid Test
Generic Name
Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing
Model / Reference
01005-5
Primary DI / UDI-DI
00045611010055
FDA Product Code
NGA
GMDN Term
Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing
Device Class
Class I
Regulation Number
862.1300
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