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U.S. Department of Health and Human Services

Product Classification

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Device anti-phospholipase a2 receptor
Definition The test system is intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.
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 Microbiology
Review Panel Immunology
Product CodePGV
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5780
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review
Accredited Persons