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Ortho said that its fully automated technology helps extend antigen phenotyping and ensures delivery of safe blood to transfusion patients.
The final guidance seeks to streamline the process, which has typically required separate submission processes for the drug and the device.
The system, which was launched in Europe earlier this year, helps eliminate preanalytical errors by automatically detecting patient tube parameters.
The in vitro diagnostic test can deliver molecular results from whole blood samples in less than three hours, the company said.
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 can be used to help doctors in the emergency room diagnose heart attacks faster and more accurately than other troponin tests on the market, Abbott said.
The agency has approved the use of Exact's Cologuard test for average-risk individuals aged 45 and older.
The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
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.