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Nuclein’s DASH SARS-CoV-2 & Flu A/B Test gains FDA clearance and CLIA waiver
Nuclein’s DASH SARS-CoV-2 & Flu A/B Test, which is designed for use with the DASH Rapid PCR System, has gained the US Food ...
JD Supra9d
What the New CLIA Rules Mean for Labs and At-Home Testing
New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that ...
Longview News-Journal10d
Nuclein Receives Dual FDA 510(k) Clearance and CLIA Waiver for DASH® SARS-CoV-2 & Flu A/B Test for use on the DASH® Rapid PCR System
With its 15-minute runtime, the DASH ® SARS-CoV-2 & Flu A/B Test utilizes a single, patient-friendly, anterior nasal swab to simultaneously test for COVID-19, influenza A, and influenza B using a ...
Morningstar7d
Trinity Investors Celebrates Nuclein’s Dual FDA Clearance and CLIA Waiver for DASH® SARS-CoV-2 & Flu A/B Test
Nuclein has secured U.S. Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for its DASH® SARS-CoV-2 & Flu A/B Test, designed for ...