Business Insights
Diagnostic Technologies
Diseases
Point-of-Care Testing
Research & Development
Sign In
About Us
Careers
Videos
Webinars
Press Releases
Whitepapers
Advertising
FDA Clearance: Page 2
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
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
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
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
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
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
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
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
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
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
Diasorin receives FDA 510(k) clearance for fungal infection panel
By
LabPulse.com staff writers
Diasorin has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Liaison Plex Yeast Blood Culture assay, the second molecular multiplexing panel developed for the firm's Liaison Plex system.
June 6, 2024
BioMérieux TBI test receives FDA 510(k) clearance
By
LabPulse.com staff writers
BioMérieux has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its assay that screens for mild traumatic brain injury, including concussion.
May 29, 2024
Previous Page
Page 2 of 9
Next Page