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NEW YORK ─ Mesa Biotech said on Wednesday it has received US Food and Drug Administration 510(k) clearance and a CLIA waiver for its Accula Strep A molecular test.

The firm said that its visually-read Strep A cassette, which fits in the palm of a hand, has been cleared for the detection of Group A Streptococcus bacterial nucleic acid to diagnose children and adults.

Accula Strep A uses RT-PCR to detect Strep A using throat, nasal, or nasopharyngeal swab samples and provides results in 30 minutes at the point of care, Mesa Biotech added.

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