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Snapshot 2026-10-12 · Link to EUDAMED

Legacy device

INSTI HIV Self Test (no pipette variant, packaged in a pouch)

UDI-DI 00686597201794Basic UDI-DI B-00686597201794

Unknown class · IVDD (legacy) · bioLytical Laboratories Inc.

Identification
Model
90-1041-014 and 90-1041-015
Issuing agency
GS1
Device status
active
Sterile
No
Manufacturer

bioLytical Laboratories Inc.

SRN CA-MF-000023304

CA · Richmond

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

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/insti-hiv-self-test-no-pipette-variant-packaged-in-a-pouch-1794 · UDI page: /udi/00686597201794

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