Sera, Reactive And Non-specific Control, Fta-abs Test

Device Code: 3169

Product Code(s): GMR

Device Classification Information

• Device Type ID: 3169
• Device Name: Sera, Reactive And Non-specific Control, Fta-abs Test
• Regulation Description: Treponema Pallidum Treponemal 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: 866.3830 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GMR
• 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: 3169
• Device: Sera, Reactive And Non-specific Control, Fta-abs Test
• Product Code: GMR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Treponema Pallidum Treponemal Test Reagents.
• CFR Regulation Number: 866.3830 [🔎]

TPLC Last Update: 2019-04-02 20:24:55