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Ibl GmbH
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LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA is an FDA 510(k)-cleared medical device (K040923) manufactured by Ibl GmbH. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 21, 2004. Regulation: 8.