The test detects Group A Strep in throat swab samples using the firm's rapid molecular diagnostics instrument called Revogene.
The Optigen AP 3600 can process up to 100 panels, or as many as 3,600 individual allergen results, in one day, and allows for true walk-away time, the firm said.
BioMérieux received clearance for its Vitek 2 gram-negative susceptibility card as a test used to determine the antimicrobial susceptibility of certain aerobic bacilli.
IL said that the rapid basic metabolic panel is designed for testing at the point of care, primarily in hospital emergency departments and clinical laboratories.
The agency said that the proposed exemption would apply only to cytometry instruments that are used for counting or characterizing cells.
The firm said that the panel is expected to receive CE marking for commercial availability in Europe later this year.
The firm said that its rapid flu detection platform helps reduce the subjectivity of interpreting test results and can be used in a broad range of healthcare settings.
The platform enables the assessment of hemoglobin levels at the point of care and quantitatively measures hemoglobin in capillary or venous whole blood.
The FDA also cleared a 23andMe genetic health risk report for a syndrome associated with a higher risk of developing hereditary colorectal cancer.
The FDA granted de novo classification for eight probes for detecting chromosomal rearrangements reported in acute myeloid leukemia and myelodysplastic syndromes.