Rapid Response D3.4-1G29

Rapid Response D3.4-1G29 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 3 Jun 2020 (UDI-DI 10722066005139), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10722066005139 UDI-DI	Date3 Jun 2020Listed	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 10722066005139
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 10722066005139 listed 3 Jun 2020 Listed

Timeline

2 dated events

6 Jul 2016 Cleared FDA 510(k) K161044
3 Jun 2020 Listed FDA GUDID 10722066005139

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Withdrawn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: D3.4-1G29

Primary DI / UDI-DI: 10722066005139
510(k) Number: K161044
FDA product code: DIO, LDJ, DJC
GMDN term: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Device class: Class II
Regulation number: 862.3250, 862.3870, 862.3610
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
Prescription use
Over-the-counter
Lot / batch number
Expiration date

Other properties (10, all answered No)