Immunohistochemistry Antibody Assay, C-kit

Device Code: 4898

Product Code(s): NKF

Definition: Identification/Intended Use - The Anti-c-KIT Primary Antibody Is Intended For Laboratory Use, Via Light Microscopy, For The Qualitative Detection Of KIT Protein In Formalin-fixed, Paraffin-embedded Gastrointestinal Stromal Tumors (GISTs) Using Either

Device Classification Information

• Device Type ID: 4898
• Device Name: Immunohistochemistry Antibody Assay, C-kit
• Regulation Description: Immunohistochemistry Reagents And Kits.
• Regulation Medical Specialty: Hematology
• Review Panel: Pathology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: PMA
• CFR Regulation Number: 864.1860 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: NKF
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-219 CLSI I/LA28-A2
  Quality Assurance For Design Control And Implementation Of Immunohistochemistry Assays; Approved Guidelines-Second Edition.

Total Product Life Cycle

• Device Type ID: 4898
• Device: Immunohistochemistry Antibody Assay, C-kit
• Product Code: NKF
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Immunohistochemistry Reagents And Kits.
• CFR Regulation Number: 864.1860 [🔎]

TPLC Last Update: 2019-04-02 20:57:12