Kit, Identification, Mycobacteria

Device Code: 3354

Product Code(s): JSY

Device Classification Information

• Device Type ID: 3354
• Device Name: Kit, Identification, Mycobacteria
• Regulation Description: Microorganism Differentiation And Identification Device.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 866.2660 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JSY
• 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: 3354
• Device: Kit, Identification, Mycobacteria
• Product Code: JSY
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Microorganism Differentiation And Identification Device.
• CFR Regulation Number: 866.2660 [🔎]

TPLC Last Update: 2019-04-02 20:28:07