Instrument For Auto Reader Of Overnight Microorganism Identification System

Device Code: 3445

Product Code(s): LRH

Device Classification Information

• Device Type ID: 3445
• Device Name: Instrument For Auto Reader Of Overnight Microorganism Identification System
• 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: LRH
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-190 CLSI M50-A (Replaces M50-P)
  Quality Control For Commercial Microbial Identification Systems; Approved Guideline
• 7-197 CLSI M35-A2 (Replaces M35-A)
  Abbreviated Identification Of Bacteria And Yeast; Approved Guideline - Second Edition.

Total Product Life Cycle

• Device Type ID: 3445
• Device: Instrument For Auto Reader Of Overnight Microorganism Identification System
• Product Code: LRH
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Microorganism Differentiation And Identification Device.
• CFR Regulation Number: 866.2660 [🔎]

Device Problems
Incorrect, Inadequate Or Imprecise Result Or Readings	5
Total Device Problems	5

TPLC Last Update: 2019-04-02 20:30:11