FDA Clearance

Roche gets FDA 510(k) clearance for B-cell lymphoma assay
By LabPulse.com staff writers
Roche has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its assay designed to aid in the diagnosis of B-cell lymphoma.
January 13, 2025
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BioMérieux's Biofire tropical fever panel gets special 510(k) clearance
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted special 510(k) clearance to BioMérieux's syndromic tropical fever panel, developed in conjunction with U.S. government agencies.
December 9, 2024
Infectious Diseases Research Social
Caris Life Sciences gets FDA approval for CDx
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Caris Life Sciences' MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from targeted treatments.
November 6, 2024
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Qiagen receives FDA clearance for respiratory mini-panel
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared Qiagen's respiratory mini-panel, which is designed to aid in the diagnosis of five respiratory pathogens, for clinical use.
October 29, 2024
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FDA greenlights first non-EUA at-home flu and COVID-19 test
By LabPulse.com staff writers
Healgen Scientific's test targets proteins from both SARS-CoV-2 and flu A and B, plus updated FDA test listings.
October 8, 2024
Influenza B virus particles, colorized blue, via National Institute of Allergy and Infectious Diseases (NIAID).
NowDiagnostics at-home syphilis test gets boost from Labcorp agreement
By LabPulse.com staff writers
STI National Strategic Plan aims to reverse recent rise of STIs.
October 10, 2024
Syphilis Treponema Bacteria Social
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
Sepsis Bacteria Social
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
Multiple Myeloma Social
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