The following data is part of a premarket notification filed by Biofire Defense, Llc with the FDA for Biofire Covid-19 Test 2.
| Device ID | K211079 |
| 510k Number | K211079 |
| Device Name: | BioFire COVID-19 Test 2 |
| Classification | Respiratory Specimen Nucleic Acid Sars-cov-2 Test |
| Applicant | BioFire Defense, LLC 79 W 4500 S, Suite 14 Salt Lake City, UT 84107 |
| Contact | Cynthia Phillips |
| Product Code | QQX |
| CFR Regulation Number | 866.3981 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-12 |
| Decision Date | 2021-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851458005235 | K211079 | 000 |
| 00851458005228 | K211079 | 000 |