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SURESIGN™ Early Detection Pregnancy Test 01001-7

by Guangzhou Decheng Biotechnology Co., LTD GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00045611010017 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  • Withdrawn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™ Early Detection Pregnancy Test
Generic Name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Model / Reference
01001-7
Primary DI / UDI-DI
00045611010017
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.

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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