Veritor SARS-CoV-2 COVID Rapid Detection Kit
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Description
The BD Veritor SARS-CoV-2 COVID Rapid Detection Kit is a cutting-edge diagnostic tool designed to swiftly and accurately detect the presence of SARS-CoV-2 antigens in nasal swabs from individuals exhibiting COVID-19 symptoms. This chromatographic immunoassay offers a reliable and convenient solution for identifying potential COVID-19 cases, allowing for prompt intervention and containment.
The BD Veritor SARS-CoV-2 COVID Rapid Detection Kit includes all the essential components necessary for reliable and convenient testing. With its rapid results and high sensitivity, this kit empowers healthcare professionals to efficiently screen individuals suspected of having COVID-19, contributing to the early identification and management of cases.
Features
- 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/emergency-situations-medical-devices/emergency-use-authorizations
- 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
- 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
- BD Veritor™ System for Rapid Detection of SARS-CoV-2 is a chromatographic digital immunoassay intended for the direct and qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swabs from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms
Product Specifications
| Number of Tests: | 30 Tests |
|---|---|
| Reading Type: | Machine Read |
| Sample Type: | Nasal Swab Sample |
| Storage Requirements: | USP Controlled Room Temperature |
| Test Format: | Test Device |
| Test Method: | Chromatographic Digital |
|---|---|
| Test Name: | SARS-CoV-2 |
| Test Type: | Infectious Disease Immunoassay |
| Time to Results: | 15 Minute Results |
| UNSPSC Code: | 41116144 |
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