
Euro-Diagnostica AB
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IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT is an FDA 510(k)-cleared medical device (K971464) manufactured by Euro-Diagnostica AB. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 1997. Regulation: 8.