LIM — Test, Screening, For D Positive Fetal Rbc'S Class II

FDA Device Classification

FDA product code LIM covers "Test, Screening, For D Positive Fetal Rbc'S", a Class II medical device regulated under 21 CFR 864.7455. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.