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Rapid Response FOB-9C2

by BTNX Inc

Rapid Response FOB-9C2 is a Class II device made by BTNX Inc, listed in FDA GUDID since 15 Jun 2023 (UDI-DI 10722066007102), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10722066007102 UDI-DI Date15 Jun 2023ListedStatusListed 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  • Withdrawn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
Rapid Response
Generic name
Faecal occult blood IVD, kit, rapid ICT, self-testing
Model / reference
FOB-9C2
Primary DI / UDI-DI
10722066007102
FDA product code
KHE
GMDN term
Faecal occult blood IVD, kit, rapid ICT, self-testing
Device class
Class II
Regulation number
864.6550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Faecal occult blood IVD, kit, rapid ICT, clinicalFaecal occult blood IVD, kit, rapid ICT, self-testing

Similar devices

Other devices filed under FDA product code KHE (Reagent, Occult Blood).

Other devices from BTNX Inc

See all devices from BTNX Inc →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)