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Anti-Müllerian Hormone Test System

FDA product code PQO · 4 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1092
Review panel
TX
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-11-13 – 2023-06-02

An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women.

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