A rapid immunoassay for simultaneous detection and differential diagnosis of SARS-CoV-2, influenza type A, and type B antigens from nasal and nasopharyngeal swab specimens. Provides results in 15 minutes with FDA 510(k) clearance and CLIA waiver status.
Manufactured by
United States
LifeSign/PBM is a medical diagnostics company delivering rapid point of care testing products to the clinical laboratory. Their products are used worldwide for the detection of infectious disease, women's health, drugs of abuse and cardiac markers. Products are developed and manufactured under ISO, cGMP and CE guidelines and supported with quality standards by their team of sales, technical and customer service professionals.
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Famwell · United States
FDA 510(k) cleared and CLIA waived cassette-format test for rapid detection of influenza A and B antigens from nasopharyngeal swabs. Provides results within 10 minutes with 85.7% positive predictive accuracy and high negative predictive accuracy. Packaged in boxes of 25 tests with 18-month shelf life.
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