Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

Device Code: 4902

Product Code(s): NQF

Definition: The Epidermal Growth Factor Receptor (EGFR) Antibody/assay Is A Qualitative Immunohistochemical Antibody/assay To Identify EGFR Expression In Normal And Neoplastic Tissues Routinely-fixed For Histological Evaluation. EGFR Antibody/assay Specifically

Device Classification Information

Device Type ID4902
Device NameImmunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
Regulation DescriptionImmunohistochemistry Reagents And Kits.
Regulation Medical SpecialtyHematology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission TypePMA
CFR Regulation Number864.1860 [🔎]
FDA Device ClassificationClass 3 Medical Device
Product CodeNQF
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4902
DeviceImmunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
Product CodeNQF
FDA Device ClassificationClass 3 Medical Device
Regulation DescriptionImmunohistochemistry Reagents And Kits.
CFR Regulation Number864.1860 [🔎]
TPLC Last Update: 2019-04-02 20:57:15

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