
Bio-Rad Laboratories, Inc.
Free shipping on orders over $99 · 30-day returns
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software is an FDA 510(k)-cleared medical device (K171664) manufactured by Bio-Rad Laboratories, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 12, 2017. Regulation: 8.