Urinalysis
News on urine-based diagnostic testing.
FDA Grants 510(k) Clearances to Beckman Coulter, Siemens, Sectra, Others
The clearances issued last month include assays to aid the diagnosis and treatment of acute and chronic diseases, an automated sepsis testing system, and two COVID-19 tests.
Scotland's Microplate Dx Secures £2.5M Seed Funding
The firm plans to use the funding to advance clinical trials for urinary tract infection antimicrobial susceptibility testing.
FDA Warns Against Use of Universal Meditech Tests
The agency said Universal Meditech has ceased operations, including support of 15 pregnancy and women's health products, all of which should be disposed of in the trash.
DxVx Secures $2.8M Government Contract for Urine-Based Disease Monitoring
The South Korean firm aims to identify biomarkers and develop an instrument capable of early diagnosis of diseases including diabetes and prostate cancer.
Meridian Bioscience, Beckman Coulter, Selux Diagnostics, Arkray Nab FDA Clearances in April
Tests for Shiga toxins, procalcitonin, antimicrobial susceptibility, and urine chemistry were among products granted US Food and Drug Administration clearances.