Antibodies, Anti-Actin, Anti-Smooth Muscle
- US Risk Class (FDA)
- Class 2
- Medical specialty
- Immunology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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.
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Antibodies, Anti-Actin, Anti-Smooth Muscle is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.