Rapid Response BUP-1C5-40

Rapid Response BUP-1C5-40 is a Class II device made by BTNX Inc, cleared under FDA 510(k) K161044 on 6 Jul 2016 and listed in FDA GUDID since 7 Feb 2019 (UDI-DI 00722066000496), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00722066000496 UDI-DI	Date7 Feb 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK161044	Date6 Jul 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00722066000496
FDA 510(k) database 510(k) number K161044

Across registries

2 registries list this device

FDA 510(k) K161044 decided 6 Jul 2016 Active
FDA GUDID UDI-DI 00722066000496 listed 7 Feb 2019 Listed

Timeline

2 dated events

6 Jul 2016 Cleared FDA 510(k) K161044
7 Feb 2019 Listed FDA GUDID 00722066000496

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Rapid Response
Generic name: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / reference: BUP-1C5-40

Primary DI / UDI-DI: 00722066000496
510(k) Number: K161044
FDA product code: DJG
GMDN term: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Device class: Class II
Regulation number: 862.3650
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

Other devices from BTNX Inc

See all devices from BTNX Inc →

Properties

Single use
Lot / batch number
Expiration date

Other properties (12, all answered No)