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Flo 1

by Co-Innovation Biotech Co., Ltd GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970429840195 UDI-DIDate31 Mar 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  • Withdrawn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
Flo
Generic Name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Model / Reference
1
Primary DI / UDI-DI
06970429840195
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 (K213808)

Other devices from Co-Innovation Biotech Co., Ltd

See all devices from Co-Innovation Biotech Co., Ltd →

Properties

  • Single Use
  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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