Prealbumin, Fitc, Antigen, Antiserum, Control

Device Code: 2943

Product Code(s): DDS

Device Classification Information

Device Type ID2943
Device NamePrealbumin, Fitc, Antigen, Antiserum, Control
Regulation DescriptionPrealbumin Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.5060 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDDS
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2943
DevicePrealbumin, Fitc, Antigen, Antiserum, Control
Product CodeDDS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPrealbumin Immunological Test System.
CFR Regulation Number866.5060 [🔎]
TPLC Last Update: 2019-04-02 20:21:32

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