System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

Device Code: 3511

Product Code(s): NJO

Definition: A Mycolic Acids Analysis System Is Intended To Aid In The Identification Of M. Tuberculosis And Differentiation From Other Mycobacteria Species Through The Analysis Of Mycolic Acids Derived From Cultured Bacterial Samples, Using High Performance Liqu

Device Classification Information

• Device Type ID: 3511
• Device Name: System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
• Regulation Description: Mycobacterium Tuberculosis Immunofluorescent Reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.3370 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: NJO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-200 CLSI M48-A (Replaced M48-P)
  Laboratory Detection And Identification Of Mycobacteria; Approved Guideline
• 7-285 CLSI M48-A 2nd Edition
  Laboratory Detection And Identification Of Mycobacteria

Total Product Life Cycle

• Device Type ID: 3511
• Device: System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
• Product Code: NJO
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Mycobacterium Tuberculosis Immunofluorescent Reagents.
• CFR Regulation Number: 866.3370 [🔎]

Device Problems
Incorrect Software Programming Calculations	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:31:27