Antigen, Cf, Typhus Fever Group

Device Code: 3232

Product Code(s): GPO

Device Classification Information

• Device Type ID: 3232
• Device Name: Antigen, Cf, Typhus Fever Group
• Regulation Description: Rickettsia Serological Reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 866.3500 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: GPO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3232
• Device: Antigen, Cf, Typhus Fever Group
• Product Code: GPO
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Rickettsia Serological Reagents.
• CFR Regulation Number: 866.3500 [🔎]

TPLC Last Update: 2019-04-02 20:26:06