Description
- The BD Veritor™ System for Rapid Detection of SARS-CoV-2 is for use under an Emergency Use Authorization ONLY: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests
- Product ships with minimum 60 days dating
- This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
- Positive results do not rule out bacterial infection or co-infection with other viruses
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
- Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
- Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management
- The BD Veritor System for Rapid Detection of SARS-CoV-2 is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings
- In the United States, the BD Veritor™ System for Rapid Detection of SARS-CoV-2 is only for use under the Food and Drug Administration’s Emergency Use Authorization
| SKU # | 1170197 |
| Manufacturer # | 256082 |
| Brand | BD Veritor™ System |
| Manufacturer | BD |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| CLIA Classified | CLIA Waived |
| Contents 1 | (30) Single-use Test Devices, (30) Single-use Reaction Tubes, (30) Sterile Single-use Specimen Sampling Swabs, Positive SARS-CoV-2 Control Swab, Negative SARS-CoV-2 Control Swab, Instructions for Use, Quick Reference Card, Nasal Sampling Instructions |
| For Use With | For use with the BD Veritor™ Plus Analyzer running Firmware version 5.4 or later |
| Is_Active_Vendor | Y |
| Is_DSCSA | N |
| Is_Discontinued | N |
| Is_Medical_Device | N |
| Lot_Tracking_Flag | Y |
| Number of Tests | 30 Tests |
| On_Allocation | N |
| Product Dating | McKesson Acceptable Dating: we will ship >= 60 days |
| Purchase Program Type | Standard Purchase |
| Reading Type | Machine Read |
| Sample Type | Nasal Swab Sample |
| Specialty | Immunoassay |
| Supplier_ID | 488246 |
| Test Format | Test Device Format |
| Test Kit Type | Rapid |
| Test Method | Chromatographic Digital Immunoassay |
| Test Name | SARS-CoV-2 |
| Test Type | Infectious Disease Immunoassay |
| Time to Results | 15 Minute Results |
| UNSPSC Code | 41116144 |
