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U.S. Department of Health and Human Services

Product Classification

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Device control material, her-2/neu, immunohistochemistry
Regulation Description Immunohistochemistry reagents and kits.
Definition Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeNJW
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.1860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible