Skip to content

Amacr (QR108)

by biocyc Biotechnologie GmbH & Co. KG 2 variants

Ref P-A004-150, P-A004-70, C-A004-05, P-A004-30, C-A004-025, C-A004-10

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42555978ANTIBODYA0042T Basic UDI-DI Date24 Nov 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
P-A004-150, P-A004-70, C-A004-05, P-A004-30, C-A004-025, C-A004-10
Primary DI / UDI-DI
04255597803442, 04255597803435, 04255597803404, 04255597803428, 04255597803862, 04255597803411
Basic UDI-DI
42555978ANTIBODYA0042T
Direct Marketing DI
04255597803442
04255597803435
04255597803404
04255597803428
04255597803862
04255597803411
EMDN Code
W01030709 Primary antisera for immunohistology
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000031533

Other devices from biocyc Biotechnologie GmbH & Co. KG

See all devices from biocyc Biotechnologie GmbH & Co. KG →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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