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CD20 (QR094)

by biocyc Biotechnologie GmbH & Co. KG 3 variants

Ref C-C015-05, C-C030-025, C-C015-01, C-C015-10, P-C015-70, P-C015-30

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 22 Oct 2026. What this means

Overview

Our CD20 (QR094) medical device, a biocyt Biotechnologie GmbH & Co. KG antibody test, is designed for the detection of antibodies in animal tissues. This instrument is not sterile and is intended for use with biological samples.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-C-C015-05YR Basic UDI-DI Date29 Sep 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
C-C015-05, C-C030-025, C-C015-01, C-C015-10, P-C015-70, P-C015-30
Primary DI / UDI-DI
D-C-C015-05YR, D-C-C030-025GJ, D-C-C015-01YH, D-C-C015-10YJ, D-P-C015-70AJ, D-P-C015-30A6
Basic UDI-DI
B-C-C015-05YR, B-C-C030-025GJ, B-C-C015-01YH, B-C-C015-10YJ, B-P-C015-70AJ, B-P-C015-30A6
EMDN Code
W01030709 Primary antisera for immunohistology
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000031533

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

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