FDA product code SDN: Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
SDN is the FDA product code for serology test used for screening of cadaveric (non-heart-beating) donors of blood or blood products or hct/ps. It is a Unclassified device, reviewed by the Microbiology panel. Devices under SDN reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
For the qualitative detection of antibodies or antigens to infectious disease agents in human cadaveric (non-heart-beating) specimens
Classification
| Field | Value |
|---|---|
| Device name | Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps |
| Device class | Unclassified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for SDN devices
openFDA lists no recalls for product code SDN.
Frequently asked questions
What is FDA product code SDN?
SDN is the FDA product code for serology test used for screening of cadaveric (non-heart-beating) donors of blood or blood products or hct/ps. It is a Unclassified device, reviewed by the Microbiology panel.
What device class is SDN?
Unclassified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code SDN
- Run a recall and safety report across every SDN manufacturer
- Watch product code SDN 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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