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BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) R…
FDA 510(k)Class II (US FDA 510(k))
510(k) K243759
Identifiers
- 510(k) Number
- K243759 FDA 510(k)
- FDA Product Code
- PEN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3365 FDA 510(k)
- Regulation Number
- 866.3365 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) R… by BioFire Diagnostics, LLC — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243759 | Class II | Active |
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Manufacturer
- Manufacturer
- BioFire Diagnostics, LLC
Sources (1)
- FDA 510(k) K243759 24 fields · synced Jun 18, 2026