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DRI Oxycodone Assay

by Microgenics Corporation 3 variants

Ref 10015632

DRI Oxycodone Assay (10015632) is a device classified as IVD General (EU), Class II (US) made by Microgenics Corporation, registered in EUDAMED on 23 Apr 2026 (Basic UDI-DI B-00884883011625), cleared under FDA 510(k) K040411 on 27 May 2004 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00884883011625), active as of 22 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 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K040411

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00884883011625 Basic UDI-DI 00884883011625UDI-DIDate23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884883011625 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK040411 Date27 May 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00884883011625 registered 23 Apr 2026 Active
  • FDA 510(k) K040411 decided 27 May 2004 Active
  • FDA GUDID UDI-DI 00884883011625 listed 12 Sep 2016 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) K040411
  2. Listed FDA GUDID 00884883011625
  3. Registered EUDAMED B-00884883011625

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  • Withdrawn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

Generic name
Oxycodone IVD, reagent
Model / reference
10015632
Primary DI / UDI-DI
00884883011625
Basic UDI-DI
B-00884883011625
510(k) Number
FDA product code
DJG
EMDN code
W0102090123 Oxycodine
GMDN term
Oxycodone IVD, reagent
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
Germany
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.

Manufacturer details

EUDAMED SRN
US-MF-000030375
Authorised representative
B·R·A·H·M·S GmbH DE-AR-000026031

Similar devices in this category

Other devices filed under OXYCODINE.

Other devices from Microgenics Corporation

See all devices from Microgenics Corporation →

Properties

  • Single use
  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)