LHJ — Staphylococcus Aureus Protein A Insoluble Class I

FDA Device Classification

FDA product code LHJ covers "Staphylococcus Aureus Protein A Insoluble", a Class I medical device regulated under 21 CFR 866.3700. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.