Respiratory Test Kit Sofia® 2 SARS Antigen+ 25 Tests CLIA Waived KT/CS MK-1229932
$753.95
Features
- Sofia 2 SARS Antigen+ FIA received De Novo FDA clearance on March 8, 2023
- Sofia 2 SARS Antigen+ Fluorescent Immunoassay (FIA), uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2
- The Sofia 2 SARS Antigen+ FIA, with the Sofia 2 analyzer, provides automated and objective results in 10 minutes, allowing for COVID-19 testing of symptomatic patients when serial testing is started within 6 days of symptom onset
- Sofia 2 SARS Antigen+ FIA is the first FDA-cleared, 10-minute rapid antigen test for COVID-19
- Rapid results to support efficient dispositioning of patients
- Reliable results without cross-reactivity to seasonal coronaviruses
- Virena connection: Provides automated tracking, data capture, government reporting, and exclusive disease mapping
- Ready for use with Sofia 2 for nasal swab procedure
- Includes positive and negative controls
- The test does not differentiate between SARS-CoV and SARS-CoV-2
- A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay
- Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment or other patient management decisions
- Positive results do not rule out co-infection with other respiratory pathogens
- This test is intended for prescription use only and can be used in Point-of-Care settings
- Materials Not Supplied in Kit: Timer or watch, Sofia 2 Instrument, Calibration Cassette
Product Specifications
| McKesson # | 1229932 |
|---|---|
| Manufacturer # | 20405 |
| Brand | Sofia® 2 |
| Manufacturer | Quidel |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| Buy American Act (BAA) Compliant | Yes |
| CLIA Classification | CLIA Waived |
| CLIA Classified | CLIA Waived |
| Contents 1 | (25) Individually Packaged Cassettes, (25) Pre-filled Reagent Tubes (Buffer with Detergents, Reducing Agents and Proclin 300), (25) Dropper Tips, (25) Sterile Nasal Swabs, SARS Positive Control Swab, SARS Negative Control Swab, QC Card |
| For Use With | For Sofia 2 Fluorescent Immunoassay Analyzer |
| Is_ECAT | N |
| Is_GSA | Y |
| Is_VA | N |
| Number of Tests | 25 Tests |
| Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
| Purchase Program Type | Standard Purchase |
| Reading Type | Machine Read |
| Sample Type | Anterior Nasal Swab Sample |
| Specialty | Immunoassay |
| Test Format | Cassette Format |
| Test Kit Type | Rapid |
| Test Method | Fluorescence Immunoassay (FIA) |
| Test Name | SARS Antigen+ |
| Test Type | Antigen Test |
| Time to Results | 10 Minute Results |
| Trade Agreement Act (TAA) Compliant | Yes |
| UNSPSC Code | 41116144 |
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FDA Disclaimer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."