Skip to content

Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Library Prep Kit for Illumina®

by NimaGen BV

Ref RC-BRCA096-I

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-9019BK Basic UDI-DI D-9019BKUDI-DIDate20 May 2022RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Library Prep Kit for Illumina®
Model / Reference
RC-BRCA096-I
Primary DI / UDI-DI
D-9019BK
Basic UDI-DI
B-9019BK
EMDN Code
W01060203 Brca 1+2
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000022926

From the manufacturer

Manufacturer's product page: Single reaction NGS Library Prep

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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