NID — Assay, Proliferation, In Vitro, T Lymphocyte Class II
FDA product code NID covers "Assay, Proliferation, In Vitro, T Lymphocyte", a Class II medical device regulated under 21 CFR 864.5220. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NID
- Device Class
- Class II
- Regulation Number
- 864.5220
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Hematology
- Implant
- No
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 added stimulants. The T lymphocytes may be normal in number or abnormally low in number due to a natural or induced immunosuppressed state in the patient.