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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device auto-antibodies; phosphatidylserine, prothrombin, phosphatidylserine/prothrombin complex
Regulation Description Multiple autoantibodies immunological test system.
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
Product CodeOPN
Regulation Number 866.5660
Device Class 2