Influenza: Page 2

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
2022 09 02 19 52 9683 Flu Season Ahead 400
Hologic launches respiratory assays in Europe
By LabPulse.com staff writers
Both products are compliant with the European In Vitro Diagnostic Medical Device Directive (IVDD) and are being made available in time for the Northern Hemisphere's respiratory viral season, the firm said.
July 10, 2022
2022 04 29 18 14 4601 Hologic Rsna 2019 400
BD nabs CE Mark for respiratory viral panel
By LabPulse.com staff writers
The panel, a molecular diagnostic combination test for SARS-CoV-2, influenza A + B, and respiratory syncytial virus (RSV), uses a nasal swab or nasopharyngeal swab sample.
June 30, 2022
2019 05 02 23 38 2538 Check Mark 400
Seegene secures EU approval for SARS-CoV-2 assay
By LabPulse.com staff writers
The clearance will allow Seegene to market the assay to small hospitals, local clinics, and public health centers for identification of COVID-19, influenza A and B, and respiratory syncytial virus (RSV).
June 28, 2022
2021 01 08 22 21 6464 Sars Co V 2 Rna 400
FDA issues EUA for Labcorp NGS test to detect SARS-CoV-2 strains
By LabPulse.com staff writers
The SARS-CoV-2 virus has mutated over time, resulting in multiple strains, also known as lineages.
June 12, 2022
2021 01 11 17 03 4617 Covid Diagnostic Test Kit 400
CorDX obtains CE Mark for test for COVID-19, flu A/B, RSV
By LabPulse.com staff writers
"As COVID-19 infection prevention measures relax globally, COVID and other viral infections are projected to rise," CorDx founder and CEO Jeff Yufeng Li said in a statement.
June 2, 2022
2021 01 11 17 03 4617 Covid Diagnostic Test Kit 400
Seegene unveils strategy for $12 COVID-19 PCR tests
By LabPulse.com staff writers
The company's "in-life PCR" initiative includes asymptomatic testing for early virus detection and syndromic respiratory testing, as well as boosting PCR test accessibility through affordable pricing.
May 24, 2022
2021 04 27 22 24 2298 Nasal Swab Test 400
LabPulse.com Microbiology Insider
By Brian Casey
Dear Microbiology Insider,
May 17, 2022
Visby awarded $25M to develop combined flu-COVID test
By LabPulse.com staff writers
The funds were awarded by the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) and will support continued development of the test. As it is, the company's Flu-COVID PCR test is a single-use, handheld, and all-in-one PCR device that detects and distinguishes between influenza A, influenza B, and SARS-CoV-2 from one sample.
March 27, 2022
2020 10 16 22 39 6807 Dollar Money Coronavirus Mask 400
Visby raises $100M in financing
By LabPulse.com staff writers
The funds will be used to scale production capacity from tens to hundreds of thousands of tests per month, to expand its product portfolio to include COVID plus influenza A/B combination testing and antimicrobial resistance panels, and to deliver PCR diagnostics to consumers at-home.
March 2, 2022
2019 08 05 19 10 8249 Dollar Sign 400
Roche adds SARS-CoV-2 tests to new Cobas 5800 systems
By LabPulse.com staff writers
The expansion will see the Cobas SARS-CoV-2 Qualitative and Cobas SARS-CoV-2 and Influenza A/B tests included in the Cobas 5800 system, a recently launched molecular laboratory instrument.
February 23, 2022
2020 04 14 17 10 6379 Test Tubes Rd Lab 400
DnaNudge launches 90-minute COVID test in Australia
By LabPulse.com staff writers
CovidNudge is a point-of-care test platform that consists of the DnaCartridge, a disposable and sealed lab-on-chip device, and the NudgeBox, a standalone instrument that is connected to the DnaNudge Cloud for processing.
February 15, 2022
2022 02 16 21 53 6609 Australian Flag 400
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