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SDNUnclassified

Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

Unknown
FDA source (opens on fda.gov)

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. FDA's definition for this code reads: "For the qualitative detection of antibodies or antigens to infectious disease agents in human cadaveric (non-heart-beating) specimens". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SDN
Device name
Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
FDA definition
For the qualitative detection of antibodies or antigens to infectious disease agents in human cadaveric (non-heart-beating) specimens
Device class
Unclassified
Review panel
Unknown
Submission type
Contact ODE
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SDN.