BioFire Blood Culture Identification 2 (BCID2) Panel
FDA 510(k) clearance K193519 · decided 2020-03-18
Clearance details
- K-number
- K193519
- Device name
- BioFire Blood Culture Identification 2 (BCID2) Panel
- Applicant
- Biofire Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-12-19
- Decision date
- 2020-03-18
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PEN
- Device class
- 2
- Regulation number
- 866.3365
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biofire Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Sy recall (Z-2456-2024) | BioFire Diagnostics, LLC | 2024-07-31 |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaer recall (Z-1139-2024) | BioFire Diagnostics, LLC | 2024-02-15 |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine recall (Z-0451-2024) | BioFire Diagnostics, LLC | 2023-12-01 |
| In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147 recall (Z-1251-2023) | BioFire Diagnostics, LLC | 2023-03-15 |