OBE · Class II · 21 CFR 866.5100

FDA Product Code OBE: Anti-ss-a 52 Autoantibodies

The Device Is Used For The Detection, In Human Serum Or Plasma, Of Autoantibodies To Ss-a 52. The Detection Of Ss-a 52 Autoantibodies May Aid In The Diagnosis Of Systemic Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis And Dermatomyositis.

2
Total
2
Cleared
193d
Avg days
2007
Since

FDA 510(k) Cleared Anti-ss-a 52 Autoantibodies Devices (Product Code OBE)

2 devices
1–2 of 2
No devices found for this product code.

About Product Code OBE - Regulatory Context