Product Classification

• Device: antibodies, saccharomyces cerevisiae (s.cerevisiae)
• Regulation Description: Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: NBT
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5785
• 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

Guidance Document

• Class II Special Control Guidance Document for Anti-Saccharomyces cerevisia (S. cerevisiae) Antibody (ASCA) Premarket Notifications

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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