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Rapid Response D2.12-2FC1

by BTNX Inc

Rapid Response D2.12-2FC1 is a Class II device made by BTNX Inc, cleared under FDA 510(k) K223162 on 17 Mar 2023 and listed in FDA GUDID since 26 Feb 2024 (UDI-DI 10722066008369), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K223162

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10722066008369 UDI-DI Date26 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223162 Date17 Mar 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223162 decided 17 Mar 2023 Active
  • FDA GUDID UDI-DI 10722066008369 listed 26 Feb 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223162
  2. Listed FDA GUDID 10722066008369

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rapid Response
Generic name
Cotinine IVD, kit, rapid ICT, clinical
Model / reference
D2.12-2FC1
Primary DI / UDI-DI
10722066008369
510(k) Number
FDA product code
LDJ, MKU
GMDN term
Cotinine IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3870, 862.3220
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cotinine IVD, kit, rapid ICT, clinical

Cleared under the same submission (K223162)

Similar devices

Other devices filed under FDA product code LDJ (Enzyme Immunoassay, Cannabinoids).

Other devices from BTNX Inc

See all devices from BTNX Inc →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)