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Mesa Biotech Gets 510(k) Clearance for Strep A Test

News


Abstract

Mesa Biotech has obtained the FDA's 510(k) clearance for its Accula Strep A test, a diagnostic for Group A streptococcus infection. The agency's clearance allows the test to be used to diagnose Strep A in both children and adults in point-of-care settings and delivers laboratory quality results in 30 minutes, the company said.
Key Data

  • Publication Date
    11 December 2020
  • Primary Author
    WCG Clinical
  • Source
    WCG Clinical
  • Language
    English
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