Pure Global

Antibodies, Anti-Actin, Anti-Smooth Muscle

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.

Global Registration Data
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Antibodies, Anti-Actin, Anti-Smooth Muscle
Immunology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NJF

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Class 2

21 CFR 866.5120

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Immunology

Device Characteristics

No

No

No

Eligible

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.

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