Rally #188-1-6038
BD #256038
BD Veritor™ Plus System RSV Kit (30 Test/KT)
Respiratory Test Kit, RSV, 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
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.
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.
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.
Rally # | 188-1-6038 |
Manufacturer # | 256038 |
GTIN | 00382902560388 |
Brand | BD Veritor™ System |
Manufacturer | BD |
Country of Origin | Unknown |
Application | Respiratory Test Kit |
CLIA Complexity | Waived |
For Use With | For BD Veritor™ Plus Analyzer |
Number of Tests | 30 Tests |
Reading Type | Machine Read |
Sample Type | Nasopharyngeal Swab Sample |
Specialty | Immunoassay |
Test Format | Test Device Format |
Test Kit Type | Rapid |
Test Name | Respiratory Syncytial Virus Test (RSV) |
Test Method | Chromatographic Immunoassay |
Time to Results | 10 Minute Results |
UNSPSC Code | 41116144 |
Storage Temperature | 2-30 °C (Do not Freeze) |
Shelf Life (Days) | 1095 |
Type | PPA | NPA | Results In |
Compared to Viral Culture | 91.8% (95% CI: 85.9%, 95.4%) |
93.3% (95% CI: 90.4%, 94.4%) |
10 minutes |
Compared to PCR | 81.6% (95% CI: 75.2%, 86.6%) |
99.1% (95% CI: 97.5%, 99.7%) |
10 minutes |
PPA = positive percent agreement
NPA = negative percent agreement