Lambda, Peroxidase, Antigen, Antiserum, Control

Device Code: 4910

Product Code(s): DEP

Device Classification Information

Device Type ID4910
Device NameLambda, Peroxidase, Antigen, Antiserum, Control
Regulation DescriptionImmunoglobulin (light Chain Specific) Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.5550 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDEP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID4910
DeviceLambda, Peroxidase, Antigen, Antiserum, Control
Product CodeDEP
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionImmunoglobulin (light Chain Specific) Immunological Test System.
CFR Regulation Number866.5550 [🔎]
TPLC Last Update: 2019-04-02 20:57:22

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