bioMérieux: CLIA waiver for a respiratory test
(CercleFinance.com) - bioMérieux today announced that it has received US FDA clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for its Biofire Spotfire (R) Panel Mini multiplex respiratory PCR test, in addition to the 510(k) clearance received last April.
In about 15 minutes, the new test detects five of the most common viruses causing upper respiratory tract infections: SARS-CoV-2 (responsible for Covid-19), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV) and Rhinovirus.
The Clinical Laboratory Improvement Amendments (CLIA) waiver allows the Biofire Spotfire system and its two existing respiratory panels to be used by non-laboratory professionals at the point of care.
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In about 15 minutes, the new test detects five of the most common viruses causing upper respiratory tract infections: SARS-CoV-2 (responsible for Covid-19), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV) and Rhinovirus.
The Clinical Laboratory Improvement Amendments (CLIA) waiver allows the Biofire Spotfire system and its two existing respiratory panels to be used by non-laboratory professionals at the point of care.
Copyright (c) 2023 CercleFinance.com. All rights reserved.