FDA product code JIP: Blood, Occult, Enzymatic Method, In Urine
JIP is the FDA product code for blood, occult, enzymatic method, in urine. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel. Devices under JIP reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Blood, Occult, Enzymatic Method, In Urine |
| Device class | Class II |
| Regulation | 21 CFR 864.6550 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JIP devices
openFDA lists no recalls for product code JIP.
Frequently asked questions
What is FDA product code JIP?
JIP is the FDA product code for blood, occult, enzymatic method, in urine. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel.
What device class is JIP?
Class II, regulation 21 CFR 864.6550. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JIP
- Run a recall and safety report across every JIP manufacturer
- Watch product code JIP 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.