Kit, Anaerobic Identification

Device Code: 3348

Product Code(s): JSP

Device Classification Information

• Device Type ID: 3348
• Device Name: Kit, Anaerobic Identification
• 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: JSP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-197 CLSI M35-A2 (Replaces M35-A)
  Abbreviated Identification Of Bacteria And Yeast; Approved Guideline - Second Edition.
• 7-257 CLSI M56-A
  Principles And Procedures For Detection Of Anaerobes In Clinical Specimens; Approved Guideline

Total Product Life Cycle

• Device Type ID: 3348
• Device: Kit, Anaerobic Identification
• Product Code: JSP
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Microorganism Differentiation And Identification Device.
• CFR Regulation Number: 866.2660 [🔎]

Device Problems
Incorrect Or Inadequate Test Results	33
Incorrect, Inadequate Or Imprecise Result Or Readings	24
Total Device Problems	57

Recalls
Manufacturer		Recall Class	Date Posted
1	BioMerieux SA	II	Jun-12-2018
2	Biomerieux Inc	II	May-22-2017

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