FDA clearance, panel choice, accuracy, on-site speed and supplier reliability for compliant workplace programs.
New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...
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QuidelOrtho Corporation QDEL recently announced that it has been granted a CLIA Waiver by the FDA, which applies to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay). The Sofia 2 SARS ...
GenoSafe advances CLIA pathway for transatlantic ATMP development CLIA registration enables GenoSafe to support testing of ...
SAN DIEGO, CA - June 24, 2025 (NEWMEDIAWIRE) - Axim Biotechnologies, Inc. (OTCQB: AXIM), a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has ...
You run the assay. The values come back off. Not catastrophically wrong, just inconsistent enough to make you doubt everything. You've checked the protocol twice. The kit hasn't expired. But the CV is ...
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