FDA Clearance

Abionic sepsis test gets FDA 510(k) clearance
By LabPulse.com staff writers
Abionic, a diagnostics firm specializing in rapid early detection, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its IVD Capsule PSP test for sepsis.
October 3, 2024
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FDA clears marketing T2 Biosystems Candida test for pediatrics
By LabPulse.com staff writers
T2Candida Panel may get a boost.
September 16, 2024
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BioMérieux receives 510(k) certification for antimicrobial testing system
By LabPulse.com staff writers
BioMérieux has received 510(k) clearance from the U.S. Food and Drug Administration for its Vitek Reveal AST system, which reports antimicrobial susceptibility testing (AST) results directly from positive blood cultures.
August 21, 2024
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NowDiagnostics granted FDA marketing authorization for OTC syphilis test
By LabPulse.com staff writers
NowDiagnostics has been granted de novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its First To Know over-the-counter (OTC) syphilis test.
August 16, 2024
Treponema pallidum, the bacteria that cause syphilis.
Thermo Fisher gets FDA 510(k) clearance for HLA typing CDx
By LabPulse.com staff writers
Thermo Fisher's SeCore CDx HLA A Sequencing System has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use as a companion diagnostic (CDx) with Adaptimmune's T-cell receptor therapy Tecelra for synovial sarcoma.
August 7, 2024
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Labcorp gets FDA de novo authorization for solid tumor mutation liquid biopsy test
By LabPulse.com staff writers
Labcorp has received de novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its PGDx Elio Plasma Focus Dx kitted assay, a pan-solid tumor liquid biopsy test that enables tumor mutation profiling.
August 5, 2024
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Thermo Fisher Scientific gets FDA 510(k) clearance for multiple myeloma precursor assays
By LabPulse.com staff writers
Thermo Fisher Scientific received an extended 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Optilite Freelite assays for evaluating monoclonal gammopathy of undetermined significance, a precursor to multiple myeloma.
July 29, 2024
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Diasorin C. auris test gets FDA de novo authorization
By LabPulse.com staff writers
Diasorin has received de novo authorization from the U.S. Food and Drug Administration (FDA) for its test kit for Candida auris, a multidrug-resistant fungal pathogen common in healthcare settings.
July 16, 2024
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FDA approves Lilly’s Alzheimer’s disease treatment
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Kisunla (donanemab) for the treatment of Alzheimer’s disease.
July 3, 2024
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FDA greenlights BioMérieux's mini respiratory, sore throat panel for POC testing
By LabPulse.com staff writers
BioMérieux received special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel Mini respiratory viral and bacterial testing device designed for point-of-care (POC) testing.
June 28, 2024
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FDA grants 510(k) clearance to Genetic Signature for parasitic GI infection kit
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Genetic Signature's EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated molecular workflow.
June 7, 2024
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Roche garners FDA EUA for 4-in-1 respiratory panel
By LabPulse.com staff writers
Roche has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Cobas Liat SARS-CoV-2, influenza A/B, and RSV nucleic acid test.
June 10, 2024
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