FDA product code SDM: Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
SDM is the FDA product code for nucleic acid 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 SDM reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
For the qualitative detection of infectious disease agents in human cadaveric (non-heart-beating) specimens
Classification
| Field | Value |
|---|---|
| Device name | Nucleic Acid 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 SDM devices
openFDA lists no recalls for product code SDM.
Frequently asked questions
What is FDA product code SDM?
SDM is the FDA product code for nucleic acid 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 SDM?
Unclassified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code SDM
- Run a recall and safety report across every SDM manufacturer
- Watch product code SDM 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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