Product Classification

• Device: antiserum, fluorescent (direct test), all groups, n. gonorrhoeae
• Regulation Description: Neisseria spp. direct serological test reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: GTH
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3390
• 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

• cola, inc.
• global quality and regulatory services
• regulatory technology services, llc