BioFire COVID-19 Test 2
FDA 510(k) K211079 · Biofire Defense, LLC
510(k) numberK211079
Submission
- Device name
- BioFire COVID-19 Test 2
- Applicant
- Biofire Defense, LLC
Salt Lake City, UT, US - Received
- April 12, 2021
- Decision date
- November 1, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QQX – Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3981
- Specialty
- Microbiology
A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The…
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| K233453 | Applied Biosystems TaqPath COVID-19 Diagnostic PCR KitQQX · Traditional | Life Technologies Corporation | 07/10/2024SE |
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| K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsQQX · Special | Roche Molecular Systems, Inc. | 06/01/2023SE |
| K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsQQX · Traditional | Roche Molecular Systems, Inc. | 10/22/2022SE |
| K212147 | Simplexa COVID-19 DirectQQX · Traditional | Diasorin Molecular, LLC | 09/13/2022SE |
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| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitPMN · Traditional | 07/17/2026SE |
| K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control KitPRD · Traditional | 03/12/2025SE |
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire…QVR · Traditional | 03/22/2023SE |
| K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelQMV · Traditional | 10/20/2022SE |
| K221460 | BioFire COVID-19 Test 2QQX · Special | 07/25/2022SE |
| K202382 | FilmArray Global Fever Panel External Control KitPMN · Traditional | 11/20/2020SE |
| K170883 | FilmArray NGDS Warrior PanelPRD · Traditional | 06/22/2017SE |
Questions and answers
When was BioFire COVID-19 Test 2 cleared by the FDA?
BioFire COVID-19 Test 2 (K211079) received a 510(k) decision of Substantially Equivalent on November 1, 2021, 203 days after the submission was received.
What is the product code of K211079?
The FDA product code is QQX – Respiratory Specimen Nucleic Acid Sars-Cov-2 Test, a Class II (moderate risk) device regulated under 21 CFR 866.3981.