A. What is a Companion Diagnostic? B. What are some of the challenges for Chill Inc. in terms of providing the two FDA approved products described in #1 above? C. What are some difficulties of using a patch in the locations described above? D. Purified ZA2GP, antibodies, and conjugate will be required for the medical device. Based on what you learned in BIOT620, describe in detail how would you prepare, purify, and test these reagents? Prepare process maps for ZA2GP and the affinity cartridge. E. What are the design inputs and design outputs for the overall diagnostic device? F. Make a list of all the major components of the device. G. What tests should Chill Inc. perform during development to evaluate the product design? H. What tests should Chill Inc. perform on each device lot to verify the equipment is working properly? I. How would the customer know the device is working properly before testing a sample? J. If the patient enters the wrong number of hours or wrong location when prompted by the device it could lead to an erroneous result. Why? K. Prepare a package insert (instruction manual) for this Companion Diagnostic product.