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The firms previously received CE mark for a COVID-19 test on the BD Max system in March.
The BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes has been used for more than a decade to assess immune function in HIV patients.
The Italian diagnostics firm believes its test can ID patients with high viral loads rapidly who need to be treated quickly.
Fujirebio Diagnostics got the nod for a chemiluminescent enzyme immunoassay to measure levels of CA 15-3 and manage patients diagnosed with breast cancer.
The clearance for the BD FACSDuet Sample Preparation System enables it to be integrated with the BD FACSLyric Flow Cytometer.
The RT-PCR-based test, which runs on Becton Dickinson's BD Max system, simultaneously detects SARS-CoV-2, influenza A and B, and respiratory syncytial virus.
The test, which received Emergency Use Authorization from the US Food and Drug Administration in July, runs on the BD Veritor Plus Analyzer System.
The supplement adds a collection vial to the BD Onclarity test and includes performance data for the BD Viper LT and the BD COR Systems.
The Seattle-based firm believes its novel collection devices are convenient and safe enough to use at home to draw blood for many types of tests.
Federal mandates requiring frequent SARS-CoV-2 testing for nursing home employees and significant purchases of rapid antigen tests from HHS have raised concerns about capacity.