
Behring Diagnostics, Inc.
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EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS is an FDA 510(k)-cleared medical device (K962519) manufactured by Behring Diagnostics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1996. Regulation: 8.