Product code OPN

Device name

Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

Medical specialty

Immunology

Device class

2

Regulation number

866.5660

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

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

Source

FDA openFDA device classification dataset