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U.S. Department of Health and Human Services

Product Classification

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Device serology test used for screening of cadaveric (non-heart-beating) donors of blood or blood products or hct/ps
Definition For the qualitative detection of antibodies or antigens to infectious disease agents in human cadaveric (non-heart-beating) specimens
Physical State May include reagents, buffers, tubes, plates and other components necessary to run the assay
Technical Method Enzyme-linked immunosorbent assay, chemiluminescence, other antibody-antigen interaction and detection
Target Area Cadaveric (non-heart-beating) donors of blood or blood products or human cells, tissues, or cellular or tissue-based products (HCT/Ps)
Review Panel Microbiology
Product CodeSDN
Premarket Review Center for Biologics Evaluation and Research Branch (CBER)
CBER Division (CBER)
Unclassified Reason Pre-Amendment
Submission Type Contact ODE
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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