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MGC Select DAU Control Set 100202

by Microgenics Corporation

Ref 100202

MGC Select DAU Control Set 100202 is a multiple drugs of abuse IVD (EU IVDD general IVD; FDA Class I; FDA product code DIF, Drug Mixture Control Materials) made by Microgenics Corporation, registered in EUDAMED on 7 May 2026 (Basic UDI-DI B-00884883001633) and listed in FDA GUDID since 30 Oct 2017 (UDI-DI 00884883001633), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00884883001633 Basic UDI-DI 00884883001633UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884883001633 UDI-DI Date30 Oct 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00884883001633 registered 7 May 2026 Active
  • FDA GUDID UDI-DI 00884883001633 listed 30 Oct 2017 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 00884883001633
  2. Registered EUDAMED B-00884883001633

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
MGC Select DAU Control Set
Generic name
Multiple drugs of abuse IVD, control
Model / reference
100202
Primary DI / UDI-DI
00884883001633
Basic UDI-DI
B-00884883001633
FDA product code
DIF
EMDN code
W0102152009 Controls for narcotics / toxicology
GMDN term
Multiple drugs of abuse IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.3280
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 I

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I 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, control

Similar devices in this category

Other devices filed under CONTROLS FOR NARCOTICS / TOXICOLOGY.

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
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)