Product Classification

• Device: indicator, biological, liquid chemical sterilization process
• Regulation Description: Sterilization process indicator.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: MRB
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• Submission Type: 510(k)
• Regulation Number: 880.2800
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc