Product Classification

• Device: antiserum, fluorescent (direct test), all groups, n. gonorrhoeae
• Regulation Description: Neisseriaspp. direct serological test reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: GTH
• Submission Type: 510(k)
• Regulation Number: 866.3390
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.