May 11, 2022—Fujirebio Diagnostics announced that the FDA has granted de novo marketing authorization for its Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for assessing β-amyloid pathology in patients who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
Read More »FDA clears Lumipulse G CA19-9-N assay
April 2020—Fujirebio Diagnostics received FDA clearance of its Lumipulse G1200 CA19-9-N chemiluminescent enzyme immunoassay for use on the Lumipulse G1200 system. The assay provides the quantitative measurement of CA 19-9 in human serum or plasma and is for use as an aid in the management of patients diagnosed with cancer of the exocrine pancreas.
Read More »FDA clears Lumipulse G CA19-9-N assay
Feb. 21, 2020—Fujirebio Diagnostics received FDA clearance of its Lumipulse G1200 CA19-9-N chemiluminescent enzyme immunoassay for use on the Lumipulse G1200 system.
Read More »FDA clears Lumipulse G whole PTH assay
January 2020—Fujirebio Diagnostics received FDA clearance for its Lumipulse G whole PTH assay for testing on the Lumipulse G1200 immunoassay platform. The assay can be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from calcium metabolism disorders. The fully automated assay has a reaction time of 30 minutes and uses a single test cartridge. It has demonstrated excellent precision with a coefficient of variation of ≤4.0 percent, the company reports.
Read More »FDA clears Lumipulse G whole PTH Assay
Oct. 31, 2019—Fujirebio Diagnostics received FDA clearance of its Lumipulse G whole PTH Assay for testing on the Lumipulse G1200 immunoassay platform.
Read More »Fujirebio gets breakthrough designation for Alzheimer’s IVD
Feb. 15, 2019—Fujirebio Diagnostics received breakthrough device designation from the FDA for its Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test.
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