Product Classification

• Device: dna-reagents, mycobacterium spp.
• Regulation Description: Mycobacterium tuberculosis immunofluorescent reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LQF
• Premarket Review: Division of Microbiology Devices (DMD); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3370
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 7-260 CLSI MM03-3rd Edition (Replaces MM03-A2)
  Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
• 7-285 CLSI M48-A 2nd Edition
  Laboratory Detection and Identification of Mycobacteria

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc