NJF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antibodies, Anti-Actin, Anti-Smooth Muscle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5120
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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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| Record | Firm | Date | Builder |
|---|---|---|---|
| QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA (K021648) | Inova Diagnostics, Inc. | 2002-09-20 | + Add |
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