System, Test, C-reactive Protein, Rhodamine

Device Code: 2925

Product Code(s): DCH

Device Classification Information

Device Type ID2925
Device NameSystem, Test, C-reactive Protein, Rhodamine
Regulation DescriptionC-reactive Protein Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.5270 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDCH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID2925
DeviceSystem, Test, C-reactive Protein, Rhodamine
Product CodeDCH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionC-reactive Protein Immunological Test System.
CFR Regulation Number866.5270 [🔎]
TPLC Last Update: 2019-04-02 20:21:17

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