JRW — Antisera, Fluorescent, B. Parapertussis Class I

FDA Device Classification

FDA product code JRW covers "Antisera, Fluorescent, B. Parapertussis", a Class I medical device regulated under 21 CFR 866.3065. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.