22.0 Information required to be submitted for the in vitro diagnostic medical device: (1) The details of source antigen or antibody as the case may be and characterization of the same. Process control of coating of antigen or antibody on the base material like Nitrocellulose paper, strips or cards or ELISA wells etc. Detailed composition of the in vitro diagnostic medical device and manufacturing flow chart process of the in vitro diagnostic medical device showing the specific flow diagram of individual components or source of the individual components. (2) Test protocol of the in vitro diagnostic medical device showing the specifications and method of testing. In house evaluation report of sensitivity, specificity and stability studies carried out by the manufacturer.