← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
PQO — Anti-Müllerian Hormone Test System
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.
DEVICE CLASS
Class II
REGULATION
21 CFR 862.1092
MEDICAL SPECIALTY
Clinical Chemistry
REVIEW PANEL
TX
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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