Respiratory Test Kit BD Veritor™ System Respiratory Syncytial Virus Test (RSV) 2 X 30 Tests CLIA Waived by BD ID 256128

Rally #P188-1-6128
BD #256128
BD Veritor™ RSV Combo Kit (1/PK)

Combo Kit, 2 x RSV Test Kit + 1 Analyzer, Rapid Chromatographic Immunoassay, Nasopharyngeal Swab, Rx Only, CLIA Complexity Waived

Features

• Easy operation and single-button functionality may help reduce potential manual errors
• Provides intuitive sample processing with prefilled, unitized tubes
• Adapts easily to your workflow by offering 2 operational modes; Walk Away & Analyze Now
• Displays easy-to-read digital results for RSV in 10 minutes
• Provides clear, objective results by correcting for nonspecific binding and detecting positives not recognized by the unaided eye
• Downloadable test records matched to kit lot number, operator, patient or specimen ID with the BD Veritor™ InfoWiFi module or via the companion ImageMover application
• Offers result printing capabilities via USB port

The BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV fusion protein from a direct nasopharyngeal swab from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients under the age of 6 years.

Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay.

The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor System Instrument. A Certificate of Waiver is required to perform this test in a CLIA waived setting. To obtain a Certificate of Waiver, please contact your state health department.

The BD Veritor™ Plus Analyzer is a digital immunoassay instrument that is part of the BD Veritor™ Plus System. It reads assay-specific barcodes on test devices to support different assays. Results are communicated to the operator via LCD, printer, or secure connection to the facility’s information system.

The BD Veritor™ Plus Analyzer is for use with BD Veritor™ System Test Devices Only. It is intended to provide rapid test results in near-patient settings.

Important Note:

• Product is non-returnable; please make sure it is the right product before ordering.
• If put into refrigeration, do not freeze.
• For in vitro diagnostic use.
• Test kits is intended for use with the analyzer.

For the State of California:
Warning: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.