(b) If the in vitro diagnostic medical device contains any of the following then descriptive information on the following need to be provided:— (1) Animal or human fluids or derivatives thereof, rendered non-viable. (2) Cells, tissues and / or derivatives of microbial recombinant origin. 2.0 Description and specification, including variants and accessories of the in vitro diagnostic medical device 2.1 Description The device master file should include the following device descriptive information:— (a) it may include (1) what is detected; (2) its function (for example screening, monitoring, diagnostic or aid to diagnosis, staging or aid to staging of disease); (3) the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate; (4) whether it is automated or not; (5) whether it is qualitative or quantitative; (6) the type of specimen required (e.g. serum, plasma, whole blood, tissue biopsy, urine); (7) testing population;