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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

BIOFIRE® FILMARRAY® Pneumonia Panel plus

UDI-DI 00815381020321Basic UDI-DI 357302BUDI002137TL

Class D · IVDR · BioFire Diagnostics, LLC

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

IVDR 799675

EU technical documentation assessment · valid

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

Valid from 2026-08-03 · Expiry 2031-08-02

Scope not stated in certificate data.

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

Manufacturer

BioFire Diagnostics, LLC

SRN US-MF-000003311

US · Salt Lake City

manufacturer

Authorised representative: bioMérieux SA (FR-AR-000004435)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/biofire-filmarray-pneumonia-panel-plus-0321 · UDI page: /udi/00815381020321

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