BioSign® Flu A+B Rapid Test Kit
25 Tests/Kit
An In vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab and nasal aspirate/wash specimens.
Includes:
- Positive and Negative control swabs
- 25 Reagent Capsules
- 25 Flocked Nasal Swabs
- 25 test cassettes
KEY BENEFITS
- Differentiates between Influenza Type A and B on a single test device
- Produces results in 10 to 15 minutes
- Each test device includes built-in controls
- Each kit comes with external controls
- Meets FDA performance criteria for influenza tests stated in code 21 CFR 866.3328
- CLIA Complexity: Moderate complexity when used with nasal wash/aspirate samples
- CLIA Waived when used with nasal and nasopharyngeal swabs
This test is strictly intended for professional use in laboratory and Point of Care environments. Meets reclassification requirements for CLIA Waiver.
CPT CODE:
- Influenza A 87804QW
- Influenza B 87804QW-59
