# Anti-Müllerian Hormone Test System
> **Product code: PQO** · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1092
## Classification
- **FDA Product Code:** PQO
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.1092
- **Review panel:** TX
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

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.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 9
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PQO)
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