No Certificate Found

Snapshot 2026-10-10 · Link to EUDAMED

Legacy device

OraQuick HIV Self-Test

UDI-DI 00608337001518Basic UDI-DI B-00608337001518

Unknown class · IVDD (legacy) · OraSure Technologies, Inc.

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Identification

Model: 1001-0601U
EMDN: W0105090302
Issuing agency: GS1
Device status: active
Sterile: No

Manufacturer

OraSure Technologies, Inc.

SRN US-MF-000009941

US · Bethlehem

manufacturer

Authorised representative: QbD RepS BV (BE-AR-000000040)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/oraquick-hiv-self-test-1518 · UDI page: /udi/00608337001518

All devices from OraSure Technologies, Inc.

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