Skip to content

Access HCV Ab V3

by Bio-Rad

Ref B33458

Access HCV Ab V3 (B33458) is a device classified as IVD Annex II List A made by Bio-Rad, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-03610520034057), active as of 7 Nov 2026.

Active European Union

CE IVDD

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03610520034057 Basic UDI-DI 03610520034057UDI-DIDate2 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / reference
B33458
Primary DI / UDI-DI
03610520034057
Basic UDI-DI
B-03610520034057
EMDN code
W0105020303 Hcv antibody (total)
Device class
Class IVD Annex II List A
EU registration type
Legacy device (under a directive)
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000006261

Similar devices in this category

Other devices filed under HEPATITIS C VIRUS.

Other devices from Bio-Rad

See all devices from Bio-Rad →

Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)