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U.S. Department of Health and Human Services

Product Classification

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Device dna-reagents, neisseria
Regulation Description Neisseria spp. direct serological test reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLSL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3390
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia trachomatis and/or Neisseria gonorrhoea: Screening and Diagnostic Testing
Third Party Review Not Third Party Eligible
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