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OXY DRI Oxycodone 09026916 190

by Microgenics Corporation

Ref 09026916190

OXY DRI Oxycodone 09026916 190 is a device classified as IVD General (EU), Class II (US) made by Microgenics Corporation, registered in EUDAMED on 8 May 2026 (Basic UDI-DI B-07613336190791), cleared under FDA 510(k) K040411 on 27 May 2004 and listed in FDA GUDID since 26 Oct 2021 (UDI-DI 07613336190791), 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, self-declared

Class I: no certifier involved

510(k) K040411

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-07613336190791 Basic UDI-DI 07613336190791UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613336190791 UDI-DI Date26 Oct 2021ListedStatusListed 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-07613336190791 registered 8 May 2026 Active
  • FDA 510(k) K040411 decided 27 May 2004 Active
  • FDA GUDID UDI-DI 07613336190791 listed 26 Oct 2021 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 07613336190791
  3. Registered EUDAMED B-07613336190791

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  • Withdrawn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
OXY DRI Oxycodone
Generic name
Oxycodone IVD, reagent
Device name
DRI Oxycodone (200 tests) on cobas c systems
Model / reference
09026916190 EUDAMED
09026916 190 GUDID
Primary DI / UDI-DI
07613336190791
Basic UDI-DI
B-07613336190791
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
09026916190
GUDID
09026916 190
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: Oxycodone IVD, reagent

Cleared under the same submission (K040411)

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 animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (15, all answered No)