Factor Xiii A, S, Antigen, Antiserum, Control

Device Code: 2453

Product Code(s): DBT

Device Classification Information

• Device Type ID: 2453
• Device Name: Factor Xiii A, S, Antigen, Antiserum, Control
• Regulation Description: Factor XIII, A, S, Immunological Test System.
• Regulation Medical Specialty: Immunology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 866.5330 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: DBT
• 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: 2453
• Device: Factor Xiii A, S, Antigen, Antiserum, Control
• Product Code: DBT
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Factor XIII, A, S, Immunological Test System.
• CFR Regulation Number: 866.5330 [🔎]

Device Problems
Capturing Problem	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:12:38