Immunochemical, Thyroglobulin Autoantibody

Device Code: 3009

Product Code(s): JNL

Device Classification Information

• Device Type ID: 3009
• Device Name: Immunochemical, Thyroglobulin Autoantibody
• Regulation Description: Thyroid Autoantibody 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: 866.5870 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JNL
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3009
• Device: Immunochemical, Thyroglobulin Autoantibody
• Product Code: JNL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Thyroid Autoantibody Immunological Test System.
• CFR Regulation Number: 866.5870 [🔎]

Device Problems
Insufficient Information	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 20:22:32