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U.S. Department of Health and Human Services

Product Classification

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Device anti-dna indirect immunofluorescent solid phase
Regulation Description Antinuclear antibody immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeKTL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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] 
Third Party Review
Accredited Persons

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