Peroxidase Anti-peroxidase Immunohistochemical Stain

Device Code: 5023

Product Code(s): LIJ

Device Classification Information

Device Type ID5023
Device NamePeroxidase Anti-peroxidase Immunohistochemical Stain
Regulation DescriptionEnzyme Preparations.
Regulation Medical SpecialtyPathology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.4400 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeLIJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5023
DevicePeroxidase Anti-peroxidase Immunohistochemical Stain
Product CodeLIJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEnzyme Preparations.
CFR Regulation Number864.4400 [🔎]
TPLC Last Update: 2019-04-02 20:58:59

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