BioSign Flu A&B by LifeSign
BioSign Flu A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza type A and type B antigens directly from nasal specimens.
CLIA Waived.
Kit Contents:
- 25 test devices
- 25 extraction reagent capsules
- 25 sterile swabs
- 1 positive and 1 negative control swabs
Description
- 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 stetted 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
ITEM #BSP-510-25