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Microbact Staph 12S MB1561A

by Oxoid Limited

Ref MB1561A

Microbact Staph 12S MB1561A is a device classified as IVD General (EU), Class I (US) made by Oxoid Limited, registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI B-05032384128006) and listed in FDA GUDID since 28 Oct 2024 (UDI-DI 05032384128006), active as of 25 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05032384128006 Basic UDI-DI 05032384128006UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05032384128006 UDI-DI Date28 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05032384128006 registered 24 Aug 2026 Active
  • FDA GUDID UDI-DI 05032384128006 listed 28 Oct 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05032384128006
  2. Registered EUDAMED B-05032384128006

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  • Withdrawn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
Microbact Staph 12S
Generic name
Multiple bacteria species culture isolate identification control IVD, kit
Model / reference
MB1561A
Primary DI / UDI-DI
05032384128006
Basic UDI-DI
B-05032384128006
FDA product code
LQL
EMDN code
W0104080203 Gram positive - manual identification
GMDN term
Multiple bacteria species culture isolate identification control IVD, kit
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
866.2660
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 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 bacteria species culture isolate identification control IVD, kit

Similar devices in this category

Other devices filed under GRAM POSITIVE - MANUAL IDENTIFICATION.

Other devices from Oxoid Limited

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Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)