Device Dossier
Clinical chemistry hormone IVDs
Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor The Weringa Group). ARTG record, intended…
- GMDN category: CT850 - Clinical chemistry hormone IVDs
- Sponsor: The Weringa Group
Intended purpose
The Mira Fertility Max Wand product is designed to detect the level of human estrone-3-glucuronide (E3G), Luteinizing Hormone (LH), and Pregnanediol-3-gluuronide (PdG) in urine when used with the Mira Analyzer. The test results of LH and E3G can be used to identify your fertility window and predict your most fertile time; the results of PdG can help to confirm your ovulation. After testing, the results are displayed on the Mira Analyzer screen. The urinary LH, E3G, and PdG test results can be used to assist in revealing information about your fertility status during the menstrual cycle.