Product Classification

• Device: immunohistochemistry antibody assay, estrogen receptor
• Regulation Description: Immunohistochemistry reagents and kits.
• Regulation Medical Specialty: Hematology
• Review Panel: Pathology
• Product Code: MYA
• 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

• CLSI I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.