Control Material, Her-2/neu, Immunohistochemistry

Device Code: 4897

Product Code(s): NJW

Definition: Accessory To Immunohistochemistry Assays For Her2-neu. Control Material Intended For Laboratory Use To Control Her2-neu Immunohistochemistry Assays.

Device Classification Information

• Device Type ID: 4897
• Device Name: Control Material, Her-2/neu, Immunohistochemistry
• 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: 510(k)
• CFR Regulation Number: 864.1860 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NJW
• GMP Exempt: No
• Summary MR: Eligible
• 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: 4897
• Device: Control Material, Her-2/neu, Immunohistochemistry
• Product Code: NJW
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Immunohistochemistry Reagents And Kits.
• CFR Regulation Number: 864.1860 [🔎]

Device Problems
Failure To Adhere Or Bond	1
Total Device Problems	1

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