Product Classification

• Device: system, blood culturing
• Regulation Description: Microbial growth monitor.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: MDB
• Submission Type: 510(k)
• Regulation Number: 866.2560
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• CLSI M47-A Principles and Procedures for Blood Cultures

Guidance Document

• Review Criteria for Blood Culture Systems  

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.