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Immunalysis 349UR-0025

by Immunalysis Corporation

Ref 349UR-0025

Immunalysis 349UR-0025 is a 2-ethylidine-1 (EU IVDD general IVD; FDA Class II; FDA product code DJR, Enzyme immunoassay, methadone) made by Immunalysis Corporation, registered in EUDAMED on 31 Aug 2026 (Basic UDI-DI B-00840937107706), cleared under FDA 510(k) K151395 on 24 Jul 2015 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00840937107706), active as of 25 Oct 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151395

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-00840937107706 Basic UDI-DI 00840937107706UDI-DIDate31 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840937107706 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151395 Date24 Jul 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00840937107706 registered 31 Aug 2026 Active
  • FDA 510(k) K151395 decided 24 Jul 2015 Active
  • FDA GUDID UDI-DI 00840937107706 listed 31 Aug 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2140-2018 FDA Class III initiated 28 Nov 2017

    The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers, which is below the 100 ng/mL cutoff of the EDDP Specific Urine Enzyme Immunoassay with which this control is utilized.

Timeline

4 dated events

  1. Cleared FDA 510(k) K151395
  2. Listed FDA GUDID 00840937107706
  3. Recall initiated FDA recalls Z-2140-2018
  4. Registered EUDAMED B-00840937107706

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  • Withdrawn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
Immunalysis
Generic name
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
349UR-0025
Primary DI / UDI-DI
00840937107706
Basic UDI-DI
B-00840937107706
510(k) Number
FDA product code
DJR
EMDN code
W0102090110 Methadone
GMDN term
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.3620
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: 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K151395)

and 1 more cleared under K151395

Similar devices in this category

Other devices filed under METHADONE.

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)