NST · Class II · 21 CFR 866.5660

FDA Product Code NST: Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking

The Device Is An Immunoassay Indicated As An Aid In The Diagnosis Of Myasthenia Gravis, An Autoimmune Disease Characterized By Exercise-induced Muscle Weakness Temporarily Relieved By Cessation Of Exercise. Autoantibody, When Present In Serum, Interferes With The Binding Of Acetylcholine, A Neural Transmitter At The Junction Of Nerves With Muscles. Autoantibody Can Also Bind To Other Portions Of The Acetylcholine Receptor Without Interfering With Acetylcholine Binding. Presence Of Autoantibody Along With Clinical Signs And Symptoms Are Usually Highly Suggestive Of Myasthenia Gravis. Acetylcholine Receptor Autoantibody Can Also Occur In The Presence Of Autoantibodies To Other Body Substances.

4
Total
4
Cleared
154d
Avg days
2004
Since

FDA 510(k) Cleared Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking Devices (Product Code NST)

4 devices
1–4 of 4
No devices found for this product code.

About Product Code NST - Regulatory Context