FDA product code NWY: Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
NWY is the FDA product code for test, qualitative, detection of dengue igm and igg antibodies. It is a Not classified device, reviewed by the Microbiology panel. Devices under NWY reach the market by Contact FDA; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for NWY devices.
Definition
Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood.
Classification
| Field | Value |
|---|---|
| Device name | Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for NWY devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-08-27.
Frequently asked questions
What is FDA product code NWY?
NWY is the FDA product code for test, qualitative, detection of dengue igm and igg antibodies. It is a Not classified device, reviewed by the Microbiology panel.
What device class is NWY?
Not classified. Typical premarket route: Contact FDA.
Have NWY devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2008-08-27.
Next steps
- Run an FDA pathway report with predicate devices for product code NWY
- Run a recall and safety report across every NWY manufacturer
- Watch product code NWY 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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