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Roche’s STI assay panels gain FDA 510(k) clearance and CLIA waiver
Roche has received 510(k) clearance with a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver from the US Food and Drug Administration (FDA) for its cobas liat sexually transmitted ...
Pharm Exec20d
FDA Grants 510(k) Clearance to Roche’s Cobas Liat Molecular Test for Sexually Transmitted Infections
The cobas liat test aims to improve patient outcomes by offering rapid, accurate results in decentralized and community-based settings for patients at risk for chlamydia, gonorrhea, and Mycoplasma ...
manilatimes20d
Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care
More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15-49 years old, most of which are asymptomatic.1 FDA CLIA-waived tests broaden access to ...
labmate-online.com11d
Roche receives FDA clearance, CLIA waiver, for cobas® liat tests to provide point of care diagnosis of STIs
Tests broaden access to accurate, easy-to-use diagnostics for patients in a decentralised setting Roche has been granted US ...
PharmiWeb19d
Roche receives FDA clearance with CLIA waiver for…
Basel, 22 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments ...
Pharmabiz19d
US FDA grants 510(k) clearance and CLIA waiver to Roche’s cobas liat sexually transmitted infection multiplex assay panels
US FDA grants 510(k) clearance and CLIA waiver to Roche’s cobas liat sexually transmitted infection multiplex assay panels: Basel Thursday, January 23, 2025, 09:00 Hrs [IST] Roc ...
Yahoo Finance18d
Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care
Basel, 22 January 2025 - Roche (SIX: RO, ROG ... Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas® liat sexually transmitted infection (STI) multiplex assay panels.