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 Code | SDN |
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 |