
Mainline Technology, Inc.
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MAINLINE MAXIE HCG URINE PREGNANCY TEST is an FDA 510(k)-cleared medical device (K031445) manufactured by Mainline Technology, Inc.. 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 June 30, 2003. Regulation: 8.