Rapid Test Kit Infectious Disease Immunoassay Influenza A + B Nasal Swab / Nasopharyngeal Swab / Nasal Wash Sample BioSign® (25/BX 20BX/CS) by Germaine Laboratories ID BSP-510-25

Rally #56-1-0510
Germaine Laboratories #BSP-510-25
BioSign® Flu A & B Test (25 Tests/Box)

Respiratory Test Kit, Flu A+B, Rapid Immunoassay, Nasal & Nasopharyngeal Swabs (CLIA Waived) / Nasal Wash/Aspirate (Moderate Complexity), Rx Only

Features

• CLIA WAIVED for nasal swab and nasopharyngeal swab specimens
• Rapid diagnosis for early treatment
• Innovative flip test design
• Easy-to-read cassette
• Pre-measured extraction reagent capsule for increased accuracy and ease of use
• Flocked nasal swabs included for better specimen collection
• Detects H1N1 (Swine Flu)

BioSign® Flu A+B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.

Negative test results are presumptive and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

CLIA Complexity:

• Moderate Complexity when used with Nasal Wash/Aspirate Samples.
• Waived when used with Nasal and Nasopharyngeal Swabs.

Important Note:

• Restricted Product: Rx Only - Current Valid Medical License Required.
• If put into refrigeration, do not freeze.
• For in vitro diagnostic use.

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.