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The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the in vitro quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum. It is intended to be used as an aid in the determination of menopausal status in women between 42 and 62 years of age. This assay should only be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make diagnostic or treatment decisions. It is intended for in vitro diagnostic use and for prescription use only.

The picoAMH ELISA device is supplied as a reagent kit containing the following components in buffer with preservatives: - AMH/MIS (Müllerian Inhibiting Substance) Coated Microtitration strips: one strip-● holder, containing 12 strips and 96 microtitration wells with mouse monoclonal AMH antibody immobilized to the inside wall of each well. - AMH/MIS Assay Buffer: one 12 mL bottle containing protein-based buffer with preservative. - picoAMH Biotin Conjugate Ready-To-Use: one 12 mL bottle containing biotinylated ● mouse anti-AMH antibody in protein-based buffer with preservative. - picoAMH Streptavidin-Enzyme Conjugate Ready-To-Use: one 12 mL bottle containing streptavidin-HRP (horseradish peroxidase) in a protein-based buffer and preservative. - . TMB Chromogen Solution: one 12 mL bottle containing a solution of tetramethylbenzidine (TMB) in buffer with hydrogen peroxide. - Stopping Solution: one 12 mL bottle containing 0.2 M sulfuric acid. ● - Wash Concentrate A: one 60 mL bottle containing buffered saline with a nonionic ● detergent that requires a 25-fold dilution with deionized water prior to use.