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U.S. Department of Health and Human Services

Product Classification

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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
Physical State Microtiter plate coated with purified antigen, enzyme labelled anti-human antibody substrate
Technical Method ELISA
Target Area peripheral blood samples
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOPN
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5660
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible