Assay, Proliferation, In Vitro, T Lymphocyte

Device Code: 2870

Product Code(s): NID

Definition: A Device Measuring The Constituents Of Dividing DNA Or Other Pre-division Cellular Constituents To Classify The Ability Of T Lymphocytes (a Type Of Normal White Blood Mononuclear Cell) To Divide Or Proliferate In Response To Specific Or Non-specific

Device Classification Information

• Device Type ID: 2870
• Device Name: Assay, Proliferation, In Vitro, T Lymphocyte
• Regulation Description: Automated Differential Cell Counter.
• Regulation Medical Specialty: Hematology
• Review Panel: Immunology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 864.5220 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NID
• 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: 2870
• Device: Assay, Proliferation, In Vitro, T Lymphocyte
• Product Code: NID
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Automated Differential Cell Counter.
• CFR Regulation Number: 864.5220 [🔎]

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