Skip to content

Rapid Response MOP-1S3-100

by BTNX Inc

Rapid Response MOP-1S3-100 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 25 Jul 2019 (UDI-DI 00722066000588), 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

510(k) K161044

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00722066000588 UDI-DI Date25 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161044 Date6 Jul 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161044 decided 6 Jul 2016 Active
  • FDA GUDID UDI-DI 00722066000588 listed 25 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161044
  2. Listed FDA GUDID 00722066000588

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  • Withdrawn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
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / reference
MOP-1S3-100
Primary DI / UDI-DI
00722066000588
510(k) Number
FDA product code
NGL
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

Related devices

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Cleared under the same submission (K161044)

and 8 more cleared under K161044

Similar devices

Other devices filed under FDA product code NGL (Test, Opiates, Over The Counter).

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)