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.
| Device Type ID | 6012 |
| Device Name | Anti-müllerian Hormone Test System |
| Physical State | In Vitro Diagnostic Device, Reagent |
| Technical Method | Mmunoassay, Other |
| Target Area | Fertility, Diagnosis |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1092 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6012 |
| Device | Anti-müllerian Hormone Test System |
| Product Code | PQO |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.1092 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
GRANTED | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
GRANTED | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 1 |
Incorrect Or Inadequate Test Results | 1 |
| Total Device Problems | 2 |