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U.S. Department of Health and Human Services

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Device anti-rnp antibody, antigen and control
Regulation Description Antinuclear antibody immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeLKO
Submission Type 510(k)
Regulation Number 866.5100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff: Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092748.htm] 
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