RAPS

FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) ...
Yahoo Finance

Biovica Submits CLIA Lab Application for DiviTum(R)TKa Launch

UPPSALA, SWEDEN / ACCESSWIRE / October 19, 2022 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) Biovica today announces that the company has submitted its CLIA lab application, marking ...
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StockTake: Lumos submits CLIA waiver application to FDA for FebriDx

Stockhead’s Tylah Tully looks at news from Lumos Diagnostics (ASX:LDX), who has submitted its application to the FDA for CLIA waiver approval for FebriDx, a rapid point-of-care diagnostic test to ...
RAPS

FDA Issues Two Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

The US Food and Drug Administration (FDA) on Tuesday issued two draft guidances aimed at updating its recommendations for in vitro diagnostics (IVDs) seeking a waiver from requirements under the ...