
Healgen Scientific,, LLC
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Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card is an FDA 510(k)-cleared medical device (K253567) manufactured by Healgen Scientific,, LLC. 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 December 22, 2025. Regulation: 8.