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U.S. Department of Health and Human Services

Product Classification

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Device autoantibodies, skin (bullous pemphigoid 180 and bullous pemphigoid 230
Regulation Description Multiple autoantibodies immunological test system.
Definition The device is intended as an aid in the diagnosis of bullous pemphigoid.
Physical State n/a
Technical Method ELISA
Target Area n/a
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOEG
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5660
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons