Product Classification

• Device: system, test, radioallergosorbent (rast) immunological
• Regulation Description: Radioallergosorbent (RAST) immunological test system.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: DHB
• Submission Type: 510(k)
• Regulation Number: 866.5750
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• CLSI I/LA20-A2 Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline - Second Edition

Third Party Review

Not Third Party Eligible