FDA product code NJT: Immunohistochemistry Reagents And Kits
NJT is the FDA product code for immunohistochemistry reagents and kits. It is a Class I device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. Devices under NJT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 92 recalls for NJT devices, 5 initiated in the last five years.
Definition
according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemistry Reagents And Kits |
| Device class | Class I |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for NJT devices
92 product recalls in 43 recall events; 5 initiated in the last five years and 7 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2017 | 15 |
| 2018 | 12 |
| 2019 | 2 |
| 2021 | 2 |
| 2024 | 1 |
| 2025 | 4 |
Frequently asked questions
What is FDA product code NJT?
NJT is the FDA product code for immunohistochemistry reagents and kits. It is a Class I device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is NJT?
Class I, regulation 21 CFR 864.1860. Typical premarket route: 510(k) exempt.
Have NJT devices been recalled?
Yes: 92 product recalls across 43 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code NJT
- Run a recall and safety report across every NJT manufacturer
- Watch product code NJT 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.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times