Antigens, Cf (including Cf Control), Influenza Virus A, B, C

Device Code: 3197

Product Code(s): GNX

Device Classification Information

• Device Type ID: 3197
• Device Name: Antigens, Cf (including Cf Control), Influenza Virus A, B, C
• Regulation Description: Influenza Virus 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: 866.3330 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: GNX
• 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: 3197
• Device: Antigens, Cf (including Cf Control), Influenza Virus A, B, C
• Product Code: GNX
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Influenza Virus Serological Reagents.
• CFR Regulation Number: 866.3330 [🔎]

Device Problems
False Positive Result	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 20:25:29