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Aptima HIV-1 Quant Dx Assay Calibrator

by Hologic United States EUDAMED

Ref PRD-03001 EMDN W0105080903

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number54200455DIAGAPTHIV1XB Basic UDI-DIDate1 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 779052 Amended

    Technical documentation EU IVDR

    Notified body
    Notified body 2797
    Issued
    17 Nov 2025
    Expires
    8 Sep 2030
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Aptima HIV-1 Quant Dx Assay
Model / Reference
PRD-03001
Primary DI / UDI-DI
15420045509122
Basic UDI-DI
54200455DIAGAPTHIV1XB
Unit of Use DI
05420045509125
EMDN Code
W0105080903 Retrovirus standards and calibrators - inf.imm.
Device Class
Class D
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000001646
Authorised representative
Hologic BV BE-AR-000000127

Other devices from Hologic

See all devices from Hologic →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 15420045509122|54200455DIAGAPTHIV1XB 61 fields · synced 24 Oct 2026