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U.S. Department of Health and Human Services

Product Classification

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Device system, test, rheumatoid factor
Regulation Description Rheumatoid factor immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDHR
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5775
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Review Criteria for Assessment of Rheumatoid Factor(RF) In Vitro Diagnostic Devices Using Engzyme-Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephelometry [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094033.htm] 
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons