The MenoCheck? picoAMH ELISA is FDA cleared for in vitro diagnostic use as an aid in the determination of menopausal status in women between 42 and 62 years of age. This is the only AMH test with the sensitivity to quantify declining AMH concentrations in women who are entering their menopausal transition. It is a quantitative three-step sandwich immunoassay. The Ab pair was developed against specific linear epitopes on the associated dimers of AMH thus ensuring specificity and consistency of AMH detection, no detectable cross-reactivity to other isoforms of AMH, different conformations of AMH, or other TGF-Beta superfamily hormones. Calibrators are rHum AMH. Exhibits no interference by complement or heterophilic antibodies. Analytical measurable range of 2 - 11,000 pg/mL. Total 4.5 hour incubation at room temperature. For in vitro diagnostic use. Ansh Labs, located just south of Houston Texas, is an FDA registered manufacturer of diagnostic test kits, antibodies, antigens, and proteins.