Reagents, Clostridium Difficile Toxin

Device Code: 3429

Product Code(s): LLH

Device Classification Information

• Device Type ID: 3429
• Device Name: Reagents, Clostridium Difficile Toxin
• 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: LLH
• 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: 3429
• Device: Reagents, Clostridium Difficile Toxin
• Product Code: LLH
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Microorganism Differentiation And Identification Device.
• CFR Regulation Number: 866.2660 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Co.	II	Jan-17-2014

TPLC Last Update: 2019-04-02 20:29:41