Hemopexin, Antigen, Antiserum, Control

Device Code: 2889

Product Code(s): CZX

Device Classification Information

• Device Type ID: 2889
• Device Name: Hemopexin, Antigen, Antiserum, Control
• Regulation Description: Hemopexin 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: 866.5490 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CZX
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2889
• Device: Hemopexin, Antigen, Antiserum, Control
• Product Code: CZX
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hemopexin Immunological Test System.
• CFR Regulation Number: 866.5490 [🔎]

TPLC Last Update: 2019-04-02 20:20:43