510(k)

The Ithaca, New York-based firm has submitted its molecular diagnostic instrument along with a test to detect chlamydia, gonorrhea, and trichomonas.

The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.

In one of two clearances in October, DiaSorin got the nod to market its Liaison XL Zika Capture IgM II test for the detection of Zika virus IgM antibodies. 

The FDA gave the nod to Shenzhen Bioeasy Biotechnology for two lateral flow immunoassays that provide preliminary results in detecting marijuana in urine. 

The system, which was launched in Europe earlier this year, helps eliminate preanalytical errors by automatically detecting patient tube parameters.

The company's Acucy Influenza A&B test detects viral nucleoprotein antigens from nasal and nasopharyngeal swabs. 

The FDA clearance follows earlier US marketing approval for the firm's C. Difficile assay.

The device is intended for preparation of stool samples and use with Buhlmann's Fcal Turbo calprotectin test.

The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.

Roche Diagnostics got the nod for its Elecsys Anti-HAV II test for the detection of total antibodies ­­— IgG and IgM — to the hepatitis A virus.