
Diasource Immunoassays, S.A.
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25OH VITAMIN D TOTAL ELISA TEST is an FDA 510(k)-cleared medical device (K123364) manufactured by Diasource Immunoassays, S.A.. 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 July 14, 2013. Regulation: 8.