Product Classification

• Device: dna-reagents, mycobacterium spp.
• Regulation Description: Mycobacterium tuberculosisimmunofluorescent reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LQF
• Submission Type: 510(k)
• Regulation Number: 866.3370
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI MM03-A2 Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
• CLSI M48-A Laboratory Detection and Identification of Mycobacteria; Approved Guideline

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.