Antisera, Cf, Influenza Virus A, B, C

Device Code: 3196

Product Code(s): GNW

Device Classification Information

Device Type ID3196
Device NameAntisera, Cf, Influenza Virus A, B, C
Regulation DescriptionInfluenza Virus Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3330 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGNW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3196
DeviceAntisera, Cf, Influenza Virus A, B, C
Product CodeGNW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionInfluenza Virus Serological Reagents.
CFR Regulation Number866.3330 [🔎]
TPLC Last Update: 2019-04-02 20:25:27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.