The US Food and Drug Administration posted two device-related closeout letters in November.

The data compares the sensitivity of almost 200 diagnostics against a standardized set of samples.

The C-suite leaders schemed to falsely record shipments of unwanted products to distributors as sales so the company could meet revenue projections, the government charged.

The guidance document allows manufacturers to promote their dry-heat systems for mask bioburden reduction if they meet certain standards.

The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.

Already cleared to monitor the viral load in HIV-positive individuals, the test has now been approved for initial diagnosis as well.