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Rapid Response BUP-1S5-100

by BTNX Inc

Ref BUP-1S5-100

Rapid Response BUP-1S5-100 is a device classified as IVD General (EU), Class II (US) made by BTNX Inc, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI B-10722066000486), cleared under FDA 510(k) K161044 on 6 Jul 2016 and listed in FDA GUDID since 30 Dec 2019 (UDI-DI 10722066000486), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K161044

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-10722066000486 Basic UDI-DI 10722066000486UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10722066000486 UDI-DI Date30 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK161044 Date6 Jul 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10722066000486 registered 25 Sep 2026 Active
  • FDA 510(k) K161044 decided 6 Jul 2016 Active
  • FDA GUDID UDI-DI 10722066000486 listed 30 Dec 2019 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K161044
  2. Listed FDA GUDID 10722066000486
  3. Registered EUDAMED B-10722066000486

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Rapid Response
Generic name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device name
Rapid Response Buprenorphine Test Strip (Urine)
Model / reference
BUP-1S5-100
Primary DI / UDI-DI
10722066000486
Basic UDI-DI
B-10722066000486
510(k) Number
FDA product code
DJG
EMDN code
W0102090117 Buprenorphine
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.3650
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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 in this category

Other devices filed under BUPRENORPHINE.

Other devices from BTNX Inc

See all devices from BTNX Inc →

Properties

  • Single use
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)