BioFire COVID-19 Test 2— 510(k) K211079
Substantially EquivalentBiofire Defense, LLC
FDA 510(k) clearance K211079 for BioFire COVID-19 Test 2, Substantially Equivalent on 2021-11-01. 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
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code QQX
view all- K243396 — Aptima SARS-CoV-2 Assay
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- K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
- K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
- 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
- K221460 — BioFire COVID-19 Test 2
Data sourced from openFDA. This site is unofficial and independent of the FDA.