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 ...

On March 12, 2014, FDA issues a revised version of the Guidance Document “Administrative Procedures for CLIA Categorization” (the “2014 Guidance”). FDA, Guidance for Industry and FDA Staff, ...

First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S. Expands access to advanced testing with a fully automated, ...

SAN DIEGO, March 4, 2011 (GLOBE NEWSWIRE) -- TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) ("TearLab" or the "Company") announced today that it is in receipt of a communication from the U.S. Food and ...

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) established quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results ...

SAN DIEGO — TearLab Corporation did not gain approval from the U.S. Food and Drug Administration for its Clinical Laboratory Improvement Amendments certificate application, the company announced in a ...

The assay runs on Roche's cobas® i 601 analyzer, part of the cobas® Mass Spec solution. By combining mass spectrometry's sensitivity and specificity with a standardized, easy-to-use workflow, the ...

Please provide your email address to receive an email when new articles are posted on . SAN DIEGO — TearLab Corporation did not gain approval from the U.S. Food and Drug Administration for its ...

First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S. "Achieving this level of automation for a mass spectrometry assay ...