FDA product code PAQ: Test, Nr2 Antibody
PAQ is the FDA product code for test, nr2 antibody. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under PAQ reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
NR2 is an independent blood-borne marker that rules in cerebral ischemic event and rules out hemorrhage.
Classification
| Field | Value |
|---|---|
| Device name | Test, Nr2 Antibody |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PAQ devices
openFDA lists no recalls for product code PAQ.
Frequently asked questions
What is FDA product code PAQ?
PAQ is the FDA product code for test, nr2 antibody. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is PAQ?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PAQ
- Run a recall and safety report across every PAQ manufacturer
- Watch product code PAQ 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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