Product Classification

• Device: antigen, cf, (including cf control), varicella-zoster
• Regulation Description: Varicella-zoster virus serological reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: GQW
• Premarket Review: Division of Microbiology Devices (DMD); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3900
• 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

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