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The agency granted clearance for the Ansh Labs PicoAMH ELISA test, which measures the amount of Anti-Müllerian hormone in the blood.
The ID Core XT is the second molecular assay approved by the FDA for use in transfusion medicine and the first to report genotypes as final results.
Becton Dickinson got clearance for a platform and test for the rapid identification and determination of antimicrobial susceptibility of gram-negative bacteria.
The IVD kit is for use with a mass spectrometer and quantitatively measures and evaluates traditionally screened amino acids and measures up to 51 analytes.
The assay provides a presumptive diagnosis of dengue virus from patients' serum samples within the first seven days of clinical symptoms.
The agency cleared a broad array of in vitro diagnostic tests, including assays for influenza, whooping cough, sexually transmitted infections, and opioids.
Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify urothelial carcinoma patients who may benefit from the anti-PD1 immunotherapy.
The agency cleared Techlab's H. Pylori Quick Check, which provides results in 30 minutes, and the H. Pylori Check, a 96-well plate format test for labs that test large numbers of specimens.
Research has found that antibodies to the marker HMGCR are highly specific to myositis and are associated with, but not limited to, statin exposure.
Siemens Healthineers received FDA clearances for several assays, including separate allowances for tests using hemoglobin A1c, troponin I, and procalcitonin biomarkers.