Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment
Device Code: 3070
Product Code(s):
NSF Definition: In Vitro Diagnostic Test Intended As A Risk Assessment Test For The Development Of Hepatocellular Carcinoma (hcc) In Patients With Chronic Liver Diseases (cld). Elevated Afpl3% Values (= 10%) Have Been Shown To Be Associated With A Nine-fold Increase
Device Classification Information
| Device Type ID | 3070 |
| Device Name | Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment |
| Regulation Description | AFP-L3% Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NSF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3070 |
| Device | Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment |
| Product Code | NSF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | AFP-L3% Immunological Test System. |
| CFR Regulation Number | 866.6030 [🔎] |
TPLC Last Update: 2019-04-02 20:23:23