BioFire COVID-19 Test 2— 510(k) K221460
Substantially EquivalentBiofire Defense, LLC
FDA 510(k) clearance K221460 for BioFire COVID-19 Test 2, Substantially Equivalent on 2022-07-25. Applicant: Biofire Defense, LLC. Device class: 2.
Clearance details
- Applicant
- Biofire Defense, LLC
- Product code
- Code QQX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
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- K233453 — Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
More clearances from Biofire Defense, LLC
view all- K261475 — BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
- K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit
- K213362 — BioFire Global Fever Special Pathogens Panel +1 more
- K220870 — BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
- K211079 — BioFire COVID-19 Test 2
Data sourced from openFDA. This site is unofficial and independent of the FDA.