Cue Health Makes De Novo Submission to FDA for Clearance of Molecular COVID Test
Cue Health made a submission to the U.S. FDA for full clearance of its molecular COVID-19 test for at-home and point-of-care use.
Cue Health made a submission to the U.S. FDA for full clearance of its molecular COVID-19 test for at-home and point-of-care use.
Labs are finding the increased volume of COVID tests has placed significant pressure on their efforts to curb the current surge of infections.
A new COVID-19 tracking software can streamline employee compliance with OSHA standards, allowing for testing that can be self-administered and self-read.
A research team from Georgia Tech has developed flow control technology to turn simple lateral flow assays into complex biomedical assays.
Read MoreThe Tech Guide from the September 2021 issue of Clinical Lab Products includes point-of-care assays and analyzers from 17 suppliers.
Read MoreVisby Medical has received a 510(k) clearance to market its fast, single-use PCR diagnostic test for the detection of STIs.
Read MoreIn screening for sepsis in newborns, there is a need to develop sensitive, and integrated diagnostic strategies to enhance detection.
Read MoreThe product is a molecular nucleic acid amplification test that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils.
Read MorePatients can order Adaptive Biotechnologies’ T-Detect Covid online, have blood drawn at LabCorp locations or via mobile phlebotomists at their homes, and receive results via an online portal.
Read MoreThe self-administered, noninvasive saliva kits are FDA authorized for use by both individuals with and without symptoms of covid-19.
Read MoreQuest Diagnostics RC Covid-19 +Flu RT-PCR Test with the Quest Diagnostics Self-Collection Kit for Covid-19 +Flu is for prescription use by individuals who are suspected of respiratory viral infection consistent with covid-19.
Read MoreThe Allegro and its StatStrip-A companion meter now provide 18 tests to help physicians make therapeutic decisions and adjustments at the point of care.
Read MoreThe FDA CLIA-waived handheld analyzer reliably and efficiently delivers results within just 5 to 10 seconds, and it can be used in point-of-care (POC) and certificate of waiver settings, such as physicians’ offices, clinics, and other nontraditional laboratory locations.
Read MoreBoth the Accula Flu A/Flu B and RSV tests are approved for use with nasal swab collection, which is less invasive than nasopharyngeal swabs.
Read MoreThe test is designed to speed accurate diagnosis of respiratory infections while enhancing the patient experience.
Read MoreGlycated albumin provides a sensitive intermediate-term marker for glycemic control in diabetes.
Read MoreWith syphilis rates on the rise, a reverse screening algorithm offers high clinical value.
Read MoreFor point-of-care hemoglobin testing, good capillary blood sampling practices are vitally important.
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