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U.S. Department of Health and Human Services

Product Classification

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Device system, test, thyroid autoantibody
Regulation Description Thyroid autoantibody immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeJZO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5870
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Review Criteria for In Vitro Diagnostic Devices for the Assessment of Thyroid Autoantibodies using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA)
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons