OPN · Class II · 21 CFR 866.5660

FDA Product Code OPN: Auto-antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/prothrombin Complex

For The Detection Of Autoantibodies To Phosphatidylserine (ps), Prothrombin (pt), Or Phosphatidylserine/prothrombin (ps/pt) Complex In Human Serum Or Plasma. To Aid In The Diagnosis Of Certain Autoimmune Thrombotic Disorders Such As Anti-phospholipid Syndrome And Those Secondary To Systemic Lupus Erythematosus Or Other Lupus-like Diseases

1
Total
1
Cleared
318d
Avg days
2010
Since

FDA 510(k) Cleared Auto-antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/prothrombin Complex Devices (Product Code OPN)

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

About Product Code OPN - Regulatory Context