urinary tract infection

The firm hopes to seek 510(k) clearance from the US Food and Drug Administration for its combined identification and antimicrobial sensitivity test by the end of 2019.

The quantitative immunoassay measures the concentration of a novel antibiotic, plazomicin (Zemdri), using the automated clinical chemistry analyzer Beckman Coulter AU 680.

As part of the deal, which is worth at least $3 million for the first five years, Primerdesign will develop and supply 384-well plate molecular assay panels for Genesis.

The company said it expects to submit its Acuitas assay for common causes of urinary tract infections to the US Food and Drug Administration early next year.

In recent months, three firms have received US Food and Drug Administration clearance for smartphone devices that allow patient-operated urinalysis testing.

The contract supports the development of a benchtop, fully automated platform and rapid tests to detect urinary tract infections and anthrax poisoning.

The firm is taking its in-home monitoring systems for COPD and cystic fibrosis, and its professional-use sepsis confirmation system through clinical trials.

The institutes will lead a program investigating antimicrobial resistance in India and developing new diagnostic technologies to support antibiotic stewardship.

BacterioScan has entered into a sales and distribution agreement for its 216Dx system with Fisher Healthcare, part of Thermo Fisher Scientific.

The award will go toward the development of MicrobeDx's technology for detecting the presence of bacteria in clinical urine specimens and to which antibiotics they are susceptible.

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