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U.S. Department of Health and Human Services

Product Classification

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Device anti-phospholipase a2 receptor
Regulation Description Transferrin immunological test system.
Definition Intended for the qualitative determination of igg class autoantibodies against phospholipase a2 receptor (pla2r) in human serum.
Physical State slides coated with cells, fluorescein-labelled detection antibody, positive and negative controls, buffers, embedding medium, cover glasses
Technical Method indirect immunofluorescence assay (IFA)
Target Area serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodePGV
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible