Antigen, C. Difficile

Device Code: 3468

Product Code(s): MCB

Device Classification Information

• Device Type ID: 3468
• Device Name: Antigen, C. Difficile
• 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: MCB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-257 CLSI M56-A
  Principles And Procedures For Detection Of Anaerobes In Clinical Specimens; Approved Guideline

Total Product Life Cycle

• Device Type ID: 3468
• Device: Antigen, C. Difficile
• Product Code: MCB
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Microorganism Differentiation And Identification Device.
• CFR Regulation Number: 866.2660 [🔎]

Device Problems
False Positive Result	2
Failure To Calibrate	1
Total Device Problems	3

TPLC Last Update: 2019-04-02 20:30:42