Device class
Class II
Regulation 862.1092
Total clearances
3
2022-06-10 → 2023-06-02
Definition
What is 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.
Classification details
Medical specialty
Clinical Chemistry
Regulation number
862.1092
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 83418 |
CPT
|
— |
High
|
CPT code for Anti-Müllerian hormone (AMH) measurement, standard for ovarian reserve testing |
| 80053 |
CPT
|
— |
Medium
|
Comprehensive metabolic panel that may include hormone panels depending on lab configuration |
Pulse
Most recent 510(k) clearances