FDA product code NID: Assay, Proliferation, In Vitro, T Lymphocyte
NID is the FDA product code for assay, proliferation, in vitro, t lymphocyte. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under NID. The average 510(k) review took 147 days (median 147).
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.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Proliferation, In Vitro, T Lymphocyte |
| Device class | Class II |
| Regulation | 21 CFR 864.5220 |
| Review panel | IM — Immunology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NID clearance
Top NID applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cylex, Inc. | 2 | 2010-10-18 |
Most recent NID clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101911 | Cylex, Inc. | IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY | 2010-10-18 | 101 |
| K013169 | Cylex, Inc. | IMMUNE CELL FUNCTION ASSAY | 2002-04-02 | 193 |
Recalls for NID devices
openFDA lists no recalls for product code NID.
Frequently asked questions
What is FDA product code NID?
NID is the FDA product code for assay, proliferation, in vitro, t lymphocyte. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Immunology panel.
What device class is NID?
Class II, regulation 21 CFR 864.5220. Typical premarket route: 510(k).
How long does a 510(k) take for product code NID?
Across 2 cleared submissions the average was 147 days from receipt to decision (median 147).
Which companies have the most NID clearances?
Cylex, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NID
- Run a recall and safety report across every NID manufacturer
- Watch product code NID for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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