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Ansh Labs PCOCheck ELISA

Ansh Labs, LLC · Model AL-196-i · UDI-DI 00853592008172

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Description

The PCOCheck ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (AMH) in human serum, Li-Heparin and K2 EDTA plasma. This assay is not impacted by AMH post translational modifications. It is intended to be used as an aid in the determination of ovarian reserve, and stratification of women with polycystic ovarian morphology (PCOM). This assay is intended for in vitro diagnostic use.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.