Rapid Test Kit BD Veritor‚™ System Infectious Disease Immunoassay SARS-CoV-2
In stock
SKU
BD-256082
Qty Left :26
Special Price
$300.00
Regular Price
$420.00
(30 Tests per Kit)
SHORT DATED STOCK- ALL TEST KIT SUPPLIES EXPIRE JUNE 2024
NO RETURNS OR EXCHANGES
NOTE: No returns or exchanges permitted for this product. Also this product cannot be sold or shipped to Puerto Rico.
All EUA authorized COVID-19 products are non-returnable with no exceptions unless damaged in transit, product is recalled for manufacturer erformacne issues or deemed defective by the manufacturer. Buyer should beware that EUA authorized products could be revoked by FDA and removed from authorization list. Products that are revoked are non-returnable and non-refundable. Note: Manufacturer recalls are returnable for replacement product only. No Cash refund will be given for manufacturer-initiated recall.
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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
| Manufacturer # | 256082 |
| Brand | BD Veritor™ System |
| Manufacturer | BD Primary Care |
| Country of Origin | Unknown |
| Application | Rapid Test Kit |
| Contents | (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 |
| Number of Tests | 30 Tests |
| Reading Type | Machine Read |
| Sample Type | Nasal Swab Sample |
| Storage Requirements | Requires Refrigeration |
| Test Format | Test Device |
| Test Method | Chromatographic Digital |
| Test Name | SARS-CoV-2 |
| Test Type | Infectious Disease Immunoassay |
| Time to Results | 15 Minute Results |
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