Alere Flu Test Wins First CLIA Waiver For Nucleic Acid Assay
This article was originally published in The Gray Sheet
Executive Summary
Alere’s i Influenza A & B test was granted a CLIA waiver Jan. 6, a step toward moving traditionally complex molecular diagnostics to a wider array of testing settings.
You may also be interested in...
Cepheid Flu Test Wins First CLIA Waiver For PCR Panel
FDA granted both a 510(k) clearance and a waiver for point-of-care use to Cepheid’s Xpert Flu +RSV Express test – the first molecular-based, polymerase chain-reaction panel diagnostic to win a CLIA waiver.
CLIA Waiver Granted To Roche For Quick Flu Test
Roche Diagnostics was recently granted a CLIA waiver allowing use of its Cobas Liat System molecular diagnostic to detect over 30 strains of Influenza A/B in doctors' offices and clinics.
New Product Briefs
Product announcements from Medtronic, Alere, St. Jude Medical and Integrum.