510(k)

Becton Dickinson nabs FDA clearance for infectious vaginitis molecular test
The BD vaginal panel running on the high-throughput BD Cor molecular diagnostic system tests for multiple common types of vaginitis using only a swab and one test.
March 16, 2023
Bd Vaginal Panel Cor System
FDA grants clearance to Abbott for first commercial laboratory test to detect traumatic brain injury
The test runs on Abbott's Alinity i laboratory immunoassay instrument, providing a result in 18 minutes to help clinicians quickly assess concussion and triage patients, Abbott said. Negative results rule out the need for a CT scan.
March 7, 2023
Football Player Concussion Social
Copan Diagnostics receives second FDA clearance for semiautomated preanalytical processor
With this second clearance, Colibri can prepare microbial suspensions for antibiotic susceptibility testing with the BioMérieux Vitek 2 system.
October 11, 2022
Lab Virus Bacteria Research
OIG: FDA recommendations for future pandemics
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
2021 11 29 23 50 3003 Fda Button 20211129235739
Week in Review: Multicancer early detection at ESMO, DiaSorin nabs FDA clearance for COVID-19 kit, IVD industry urges Congress to enact SALSA, and more
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September 14, 2022
FDA grants 510(k) clearance to DiaSorin for COVID-19 kit
The kit, which runs on DiaSorin's Liaison MDX molecular diagnostics system, provides a sample-to-answer test for the detection of SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens.
September 13, 2022
2021 08 23 18 25 2180 Covid Treatment Doctor 400
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Genetic causes identified for three rare diseases
Researchers in study validate test to identify newborns with homocystinuria, a rare inherited disease
SARS-CoV-2 infection weakens immune-cell response to vaccination, study suggests
Duke University researchers discover biomarkers may identify early pancreatic cancer risk
Werfen completes $2B acquisition of Immucor, expands presence in specialized diagnostics
Chembio CEO urges stockholders to tender remaining shares as deadline is extended for acquisition
PixCell Medical, Insight Medical to distribute hematology analyzer
PixCell said that its HemoScreen hematology analyzer delivers lab-grade diagnostics at the point of care without the need for external reagents or extensive training.
September 5, 2022
2021 01 12 23 44 3780 Blood Test Samples Lab 400
Cue Health requests FDA de novo clearance for at-home flu test
Clearance would permit the test to be used at home and elsewhere at the point-of-care (POC).
September 1, 2022
2022 09 02 19 52 9683 Flu Season Ahead 400
NanoDx, SkyWater launch nano biosensor
The companies said that as a result of the development, NanoDx is ready to prepare and submit the product for review by the U.S. Food and Drug Administration (FDA) with the aim of eventually commercializing a product based on the technology.
August 25, 2022
2021 06 30 22 19 4138 Digital Science Lab 400
FDA issues updated reagent, instrument guidance
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
According to the FDA, Q-Subs can serve as helpful tools in the premarket submission process.
August 10, 2022
2019 10 09 23 45 4810 Lab Nipt Test 400
Abionic nabs IVDR certification for sepsis test
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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