Antibodies, Anti-actin, Anti-smooth Muscle
Device Code: 3064
Product Code(s):
NJF Definition: The Device Is Used For The Semi-quantitative Detection Of IgG Antibodies To The Actin Component Of Smooth Muscle In Human Serum As An Aid In The Diagnosis Of Certain Autoimmune Liver Diseases, E.g. Autoimmune Hepatitis.
Device Classification Information
| Device Type ID | 3064 |
| Device Name | Antibodies, Anti-actin, Anti-smooth Muscle |
| Regulation Description | Antismooth Muscle Antibody 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 | 866.5120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NJF |
| 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 | 3064 |
| Device | Antibodies, Anti-actin, Anti-smooth Muscle |
| Product Code | NJF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antismooth Muscle Antibody Immunological Test System. |
| CFR Regulation Number | 866.5120 [🔎] |
TPLC Last Update: 2019-04-02 20:23:18