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Antibodies, Anti-Actin, Anti-Smooth Muscle

FDA product code NJF · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5120
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2002-09-20 – 2002-09-20

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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