FDA Submission

Co-Diagnostics submits 510(k) applications for platform, OTC COVID-19 test
By LabPulse.com staff writers
Molecular diagnostics firm Co-Diagnostics submitted its first U.S. Food and Drug Administration application for 510(k) clearance for its Co-Dx PCR Pro instrument, along with the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use.
June 17, 2024
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Guardant's CRC screening test receives advisory committee recommendation
By LabPulse.com staff writers
Guardant's blood-based Shield screening test for colorectal cancer (CRC) has received the recommendation of the U.S. Food and Drug Administration's Medical Devices Advisory Committee, an important milestone on its path to approval.
May 28, 2024
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CorDx submits EUA application for COVID-19/influenza rapid test
By LabPulse.com staff writers
CorDx has submitted an Emergency Use Authorization (EUA) application for its CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test to the U.S. Food and Drug Administration (FDA).
February 10, 2024
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NowDiagnostics submits FDA de novo request for OTC syphilis test
By LabPulse.com staff writers
NowDiagnostics has submitted a de novo authorization request to the U.S. Food and Drug Administration (FDA) for its First to Know over-the-counter (OTC) syphilis test.
January 10, 2024
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FDA grants priority review to Merck’s pneumococcal vaccine
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted priority review to Merck’s experimental pneumococcal vaccine, with a decision to be made on approval by June 17, 2024.
December 20, 2023
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Vertex Pharmaceuticals, CRISPR Therapeutics gene-editing therapy to undergo FDA advisory committee review
By LabPulse.com staff writers
An FDA advisory committee is scheduled to meet on October 31 to discuss and make recommendations on Vertex Pharmaceuticals' and CRISPR Therapeutics’ CRISPR-Cas9 gene-editing-based therapy, exagamglogene autotemcel.
October 30, 2023
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GeninCode files pre-market notification with FDA for cardiovascular risk assessment test
By LabPulse.com staff writers
The filing is part of GeninCode’s effort to expand its U.S. commercial distribution of CIC-SCORE; the company filed its pre-submission for GeninCode with the FDA last year.
August 18, 2023
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OIG: FDA recommendations for future pandemics
By Leo O'Connor
OIG offered numerous recommendations to manage such infectious disease emergencies, saying the FDA should access and, when appropriate, revise its guidance for Emergency Use Authorization (EUA) submissions for tests.
September 21, 2022
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Cue Health requests FDA de novo clearance for at-home flu test
By LabPulse.com staff writers
Clearance would permit the test to be used at home and elsewhere at the point-of-care (POC).
September 1, 2022
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FDA issues updated reagent, instrument guidance
By LabPulse.com staff writers
The agency said that it revised the current guidance to include point-of-care in vitro diagnostic (IVD) devices in certain situations, flowcharts, updates to examples, and further clarification of terminology.
August 15, 2022
2021 11 29 23 50 3003 Fda Button 20211129235739
Natera files presubmission with FDA for NIPT test
By LabPulse.com staff writers
According to the FDA, Q-Subs can serve as helpful tools in the premarket submission process.
August 10, 2022
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Abionic nabs IVDR certification for sepsis test
By LabPulse.com staff writers
The device detects pancreatic stone protein, an early marker for sepsis, allowing for its identification in about five minutes, Abionic said.
August 8, 2022
2020 06 19 20 57 0712 Sepsis Bacteria 400
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