Reagent, Immunoassay, Igg

Device Code: 3026

Product Code(s): KTO

Device Classification Information

• Device Type ID: 3026
• Device Name: Reagent, Immunoassay, Igg
• Regulation Description: Immunoglobulin G (Fc Fragment Specific) Immunological Test System.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 866.5530 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KTO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-113 CLSI I/LA23-A (Replaces I/LA23-P)
  Assessing The Quality Of Immunoassay Systems: Radioimmunoassays, And Enzyme, Fluorescence, And Luminescence Immunoassays; Approved Guideline

Total Product Life Cycle

• Device Type ID: 3026
• Device: Reagent, Immunoassay, Igg
• Product Code: KTO
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Immunoglobulin G (Fc Fragment Specific) Immunological Test System.
• CFR Regulation Number: 866.5530 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Vitrolife Inc	II	Apr-15-2015

TPLC Last Update: 2019-04-02 20:22:47