Alpha-1-lipoprotein, Antigen, Antiserum, Control

Device Code: 2960

Product Code(s): DER

Device Classification Information

• Device Type ID: 2960
• Device Name: Alpha-1-lipoprotein, Antigen, Antiserum, Control
• Regulation Description: Alpha-1-lipoprotein 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)
• CFR Regulation Number: 866.5580 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DER
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 7-175 CLSI C59-A
  Apoplipoprotein Immunoassays: Development And Recommended Performance Characteristics; Approved Guideline

Total Product Life Cycle

• Device Type ID: 2960
• Device: Alpha-1-lipoprotein, Antigen, Antiserum, Control
• Product Code: DER
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Alpha-1-lipoprotein Immunological Test System.
• CFR Regulation Number: 866.5580 [🔎]

TPLC Last Update: 2019-04-02 20:21:45