
Sigma Diagnostics, Inc.
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NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA) is an FDA 510(k)-cleared medical device (K874115) manufactured by Sigma Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 3, 1987. Regulation: 8.