
Sciteck Diagnostics, Inc.
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UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE is an FDA 510(k)-cleared medical device (K954514) manufactured by Sciteck Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 20, 1996. Regulation: 8.