BioFire® COVID-19 Test 2
BioFire COVID-19 Test 2 detects SARS-CoV-2 RNA in nasopharyngeal swabs from symptomatic people suspected of COVID-19 by a healthcare provider. It is a qualitative in vitro diagnostic assay…
BioFire COVID-19 Test 2 detects SARS-CoV-2 RNA in nasopharyngeal swabs from symptomatic people suspected of COVID-19 by a healthcare provider. It is a qualitative in vitro diagnostic assay for BioFire FilmArray 2.0 and Torch systems, used by trained medical or laboratory professionals or under their supervision.
A single-use pouch contains freeze-dried reagents for nucleic-acid purification and nested multiplex RT-PCR. Hydration solution and the specimen mixed with sample buffer rehydrate the reagents. The instrument moves liquids through the pouch, extracts nucleic acids and performs amplification followed by DNA melt analysis.
Listed Item
BioFire® COVID-19 Test 2 – IVD reagent kit containing 30 tests
Result and Interpretation
Three independent SARS-CoV-2 tests contribute to the result, available in about 45 minutes. FilmArray software interprets melt curves and internal controls. A positive result identifies viral RNA and requires clinical correlation with other information; it does not exclude infection with additional pathogens.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
Record
| Listed by | BioFire Defense, LLC, United States |
|---|---|
| FDA product code | QQX |
| Device type | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3981 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K211079 |
| Record published | 2023-02-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DFA2-ASY-0016 | In distribution | |
| DFA2-ASY-0015 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aptima® | Hologic, Inc. | 3 |
| Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer | Life Technologies Corporation | 3 |
| COVID-19 Coronavirus Real Time PCR Kit | Jiangsu Bioperfectus Technologies Co., Ltd. | 2 |
| cobas® SARS-CoV-2 Qualitative 480T | Roche Molecular Systems, Inc. | 1 |
| Simplexa COVID-19 Positive Control GEN II Pack | DiaSorin Molecular LLC | 1 |
| GeneXpert® | Cepheid | 1 |
| BD Respiratory Viral Panel-SCV2 for BD MAX™ System | Becton, Dickinson AND Company | 1 |
| cobas® SARS-CoV-2 Qualitative Control Kit | Roche Molecular Systems, Inc. | 1 |
| Simplexa COVID-19 Positive Control Pack | DiaSorin Molecular LLC | 1 |
| Simplexa COVID-19 Direct | DiaSorin Molecular LLC | 1 |
| cobas® SARS-CoV-2 Qualitative 192T | Roche Molecular Systems, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221460 | 2022-07-25 |
| K211079 | 2021-11-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.