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Immunalysis 336UR-0100

by Immunalysis Corporation

Ref 336UR-0100

Immunalysis 336UR-0100 is a device classified as IVD General (EU), Class II (US) made by Immunalysis Corporation, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI B-00840937102718), cleared under FDA 510(k) K141406 on 1 Jul 2014 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00840937102718), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141406

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00840937102718 Basic UDI-DI 00840937102718UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840937102718 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK141406 Date1 Jul 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00840937102718 registered 17 Aug 2026 Active
  • FDA 510(k) K141406 decided 1 Jul 2014 Active
  • FDA GUDID UDI-DI 00840937102718 listed 31 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K141406
  2. Listed FDA GUDID 00840937102718
  3. Registered EUDAMED B-00840937102718

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  • Withdrawn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
Buprenorphine Urine HEIA EUDAMED
Immunalysis GUDID
Generic name
Buprenorphine IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
336UR-0100
Primary DI / UDI-DI
00840937102718
Basic UDI-DI
B-00840937102718
510(k) Number
FDA product code
DJG
EMDN code
W0102090117 Buprenorphine
GMDN term
Buprenorphine IVD, kit, enzyme immunoassay (EIA)
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
Netherlands
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: Buprenorphine IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K141406)

and 1 more cleared under K141406

Similar devices in this category

Other devices filed under BUPRENORPHINE.

Other devices from Immunalysis Corporation

See all devices from Immunalysis Corporation →

Properties

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