Visby Medical’s STI Test for Women Gets FDA Clearance, CLIA Waiver
Visby Medical has received 510(k) clearance and was granted a CLIA waiver from the FDA for its second-generation POC sexual health test.
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Search Results for: point-of-care testing
New Test Identifies Patients Whose Postoperative Pain can be Treated by Hypnosis
Investigators developed a molecular test that identifies individuals most likely to benefit from hypnosis interventions to treat pain.
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Researchers Develop Tech to Detect Active Tuberculosis Easily
A research team discovered new technology that will quickly and easily detect active Mycobacterium tuberculosis (TB) infection antibodies.
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QuidelOrtho Receives De Novo FDA Authorization for COVID Rapid Test
QuidelOrtho has been granted a De Novo request from the U.S. FDA, allowing the company to market its new Sofia 2 SARS Antigen+ FIA.
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FDA Clears Point-of-Care Fentanyl Test
Shenzhen Superbio Technology received FDA clearance for its point-of-care instrument intended for the detection of fentanyl in human urine.
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