510(k) K211079
- Device
- BioFire COVID-19 Test 2
- Applicant
- BioFire Defense, LLC
- 510(k) number
- K211079
- Product code
- QQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-01
- Date received
- 2021-04-12
- Regulation
- 866.3981
- Classification name
- Respiratory Specimen Nucleic Acid Sars-cov-2 Test
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Cynthia Phillips
- Address
- 79 W 4500 S Suite 14 Salt Lake City UT US 84107 84107
FDA Registration Numbers#
- 2024800
- 1119779
- 3010770794
- 3007420875
- 3007867838
- 3004530258
- 3016838963
- 3021140368
- 3009613136
- 3004141078
- 3009976420
- 2243471
- 3006247421
Source Documents#
Other 510(k) Records For Product Code QQX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243396 | Aptima SARS-CoV-2 Assay | Hologic, Inc. | 2025-02-13 |
| K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2025-02-11 |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Cepheid® | 2025-01-15 |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | Abbott Molecular | 2024-12-06 |
| K233453 | Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit | Life Technologies Corporation | 2024-07-10 |
| K230440 | Xpert® Xpress CoV-2 plus | Cepheid® | 2023-10-13 |
| K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems, Inc. | 2023-06-01 |
| K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc. | 2022-10-22 |
| K212147 | Simplexa COVID-19 Direct | Diasorin Molecular, LLC | 2022-09-13 |
| K221460 | BioFire COVID-19 Test 2 | Biofire Defense, LLC | 2022-07-25 |
Legacy Summary#
summary
FDA Review#
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