
E.I. Dupont DE Nemours & Co., Inc.
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ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK is an FDA 510(k)-cleared medical device (K832357) manufactured by E.I. Dupont DE Nemours & Co., Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 31, 1983. Regulation: 8.