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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
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] 
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