Healgen Strep A Rapid Test Strip (Throat Swab)

Healgen Strep A Rapid Test Strip (Throat Swab) is an FDA 510(k)-cleared medical device (K212623) manufactured by Healgen Scientific,, LLC. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 15, 2022. Regulation: 8.