NJF — Antibodies, Anti-Actin, Anti-Smooth Muscle Class II
FDA product code NJF covers "Antibodies, Anti-Actin, Anti-Smooth Muscle", a Class II medical device regulated under 21 CFR 866.5120. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NJF
- Device Class
- Class II
- Regulation Number
- 866.5120
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K021648 | inova diagnostics | QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA | September 20, 2002 |