On Monday, The US Food and Drug Administration issued an Emergency Use Authorization to Laboratory Corporation of America's Seasonal Respiratory Virus RT-PCR DTC test for use without a prescription by individuals with symptoms of COVID-19.
The US Food and Drug Administration earlier this month granted Emergency Use Authorization for Abbott's ID Now COVID-19 2.0 rapid point-of-care test.
Danaher subsidiary Cepheid announced on Thursday that its Xpert Xpress CoV-2 plus test has received Emergency Use Authorization from the US Food and Drug Administration.
Becton Dickinson has received 510(k) clearance from the US Food and Drug Administration for the MX molecular diagnostics module along with a triplex assay for chlamydia, gonorrhea, and trichomonas.
According to industry insiders, Mindray became the general agent of GenSure Biotech Inc., and officially started entered the SARS-CoV-2 antigen test business.
Hologic announced on Tuesday that its Aptima CMV Quant assay for cytomegalovirus has been approved by the US Food and Drug Administration.
OraSure Technologies reported after the close of the market on Tuesday that its first quarter revenues increased 16 percent year over year driven by 21 percent growth in non-COVID revenues.
Mindray started laying the foundation of the world's 4th largest manufacturing base. Runda actively invested in the construction of sampling stand for nucleic acid detection in Shanghai. Calibra accelerated the track of multi omics source innovation of clinical products
The US Food and Drug Administration said on Wednesday it has issued de novo classification to Fujirebio Diagnostics' Lumipulse G β-Amyloid Ratio (1-42/1-40) test, allowing the company to market it as a tool for diagnosing Alzheimer's disease.
BioMérieux said on Wednesday that its BioFire Joint Infection (JI) Panel has received de novo authorization from the US Food and Drug Administration.
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