Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae

Device Code: 3315

Product Code(s): GTH

Device Classification Information

• Device Type ID: 3315
• Device Name: Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae
• Regulation Description: Neisseria Spp. Direct Serological Test Reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.3390 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GTH
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3315
• Device: Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae
• Product Code: GTH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Neisseria Spp. Direct Serological Test Reagents.
• CFR Regulation Number: 866.3390 [🔎]

TPLC Last Update: 2019-04-02 20:27:28