Product Classification

• Device: gbs culture media, selective and differential
• Regulation Description: Selective culture medium.
• Definition: Culture Medium for GBS Detection
• Physical State: Media (broth or plates)
• Technical Method: Chromogenic agar
• Target Area: not applicable
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: PQZ
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.2360
• Device Class: 1
• 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

• global quality and regulatory services
• regulatory technology services, llc