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510(k) K221460

BioFire COVID-19 Test 2 by Biofire Defense, LLC — Product Code QQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2022
Date Received
May 19, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Device Class
Class II
Regulation Number
866.3981
Review Panel
MI
Submission Type

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 device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.

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Other clearances for product code QQX

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  • K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (January 15, 2025)
  • K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-0 (December 6, 2024)
  • K233453 — Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (July 10, 2024)
  • K230440 — Xpert® Xpress CoV-2 plus (October 13, 2023)
  • K231306 — cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (June 1, 2023)
  • K213804 — cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems (October 22, 2022)
  • K212147 — Simplexa COVID-19 Direct (September 13, 2022)
  • K211079 — BioFire COVID-19 Test 2 (November 1, 2021)