FDA Clears Simplexa Group A Strep Direct Test
CE marked and assigned to moderate complexity status in the United States, the Simplexa PCR-based strep A direct test by Focus Diagnostics is now available internationally.
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FDA Clears Group A Strep Test
Detecting group A Streptococcus bacteria from throat swab specimens in 8 minutes or less, the test is performed on the company’s i platform, using isothermal technology that amplifies nucleic acids at a constant temperature.
Read MoreNIH Funds Nine Antimicrobial Resistance Diagnostics Projects
NIAID taps investigators at academic and commercial institutions to develop tools for rapidly detecting healthcare-associated pathogens.
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Akers Biosciences Boosts Distribution
With new marketing and distribution agreements at home and abroad, Akers expands US and international distribution of its flagship rapid test for HIT—and more.
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Lab Informatics
In clinical labs, the application of modern lab informatics systems covers a growing range of uses.
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