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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Aptima HIV-1 Quant Dx Assay

UDI-DI 15420045509115Basic UDI-DI 54200455DIAGAPTHIV1XB

Class D · IVDR · Hologic

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IVDR 779052

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2025-11-17 · Expiry 2030-09-08

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Hologic

SRN US-MF-000001646

US · San Diego

manufacturer

Authorised representative: Hologic BV (BE-AR-000000127)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/aptima-hiv-1-quant-dx-assay-9115 · UDI page: /udi/15420045509115

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