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Alinity c DOA MC Negative Calibrator Kit

by Microgenics Corporation 2 variants

Ref 08P6306

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00884883008748 Basic UDI-DI 00884883008748UDI-DIDate6 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Alinity c DOA MC Negative Calibrator Kit
Model / Reference
08P6306
Primary DI / UDI-DI
00884883008748
Basic UDI-DI
B-00884883008748
EMDN Code
W01021521 Multicomponent immunochemistry controls
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

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

Other devices from Microgenics Corporation

See all devices from Microgenics Corporation →

Properties

  • Human Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No