← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

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

For the qualitative detection of antibodies or antigens to infectious disease agents in human cadaveric (non-heart-beating) specimens

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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