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U.S. Department of Health and Human Services

Product Classification
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Device nucleic acid test used for screening of cadaveric (non-heart-beating) donors of blood or blood products or hct/ps
Definition For the qualitative detection of infectious disease agents in human cadaveric (non-heart-beating) specimens
Physical State May include reagents, probes, primers, buffers, tubes, plates and other components necessary to run the assay
Technical Method Polymerase Chain Reaction (PCR), nucleic acid amplification, sequencing
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 CodeSDM
Premarket Review 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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