Total Spinal-fluid, Antigen, Antiserum, Control

Device Code: 2971

Product Code(s): DFI

Device Classification Information

Device Type ID2971
Device NameTotal Spinal-fluid, Antigen, Antiserum, Control
Regulation DescriptionTotal Spinal Fluid 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 Number866.5860 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDFI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2971
DeviceTotal Spinal-fluid, Antigen, Antiserum, Control
Product CodeDFI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTotal Spinal Fluid Immunological Test System.
CFR Regulation Number866.5860 [🔎]
TPLC Last Update: 2019-04-02 20:21:56

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