NID
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay, Proliferation, In Vitro, T Lymphocyte
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY (K101911) | Cylex, Inc. | 2010-10-18 |
| IMMUNE CELL FUNCTION ASSAY (K013169) | Cylex, Inc. | 2002-04-02 |
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Every clearance here is in the API, with alerts when new ones post.