This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The answer is that, on average, the ...
The Company plans to expand in the medical diagnostic testing space via mobile modular units. SG Blocks will own and operate these units, providing its own end-to-end solution including both staffing ...
An ethyl alcohol (ETOH) assay from Carolina Liquid Chemistries Corp. (CLC) has been categorized as moderately complex under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for use on the ...
Woman Founded and Operated, Gather Labs is the First High Complexity CLIA Laboratory and Clinic in Los Angeles County Offering COVID Testing By Appointment with Results in as Little as 10 Minutes, ...
On December 23, 2023, CMS issued its Final Rule, establishing new Clinical Laboratory Improvement Amendments (CLIA) regulations (the Final Rule). Several provisions only became effective December 28, ...
INDIANAPOLIS, Sept. 18, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has categorized its Ionify® 25-Hydroxy Vitamin D total ...
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