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Access HIV combo V2

by Bio-Rad

Ref C28430

Access HIV combo V2 (C28430) 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-03610522115808), 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-03610522115808 Basic UDI-DI 03610522115808UDI-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  • Withdrawn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
C28430
Primary DI / UDI-DI
03610522115808
Basic UDI-DI
B-03610522115808
EMDN code
W0105030404 HIV multiple ag/ab combi test
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 HIV - MULTIPLE ( 1 / 2 ).

Other devices from Bio-Rad

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Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
Other properties (7, all answered No)