Microbiology-PTM-OMA_Modules_1-5

Product Consistency (Lot‐to‐Lot Variability)

• Study to confirm that the manufacturing of the  test kit and its components is consistent among  lots • Testing is performed on 3 unique lots • Each lot must be a uniquely manufactured  lot or consist of uniquely prepared  reagents, supplies, and kit components • Can be combined with stability testing in a  single study; if tested independent of  stability testing, age of test kit is not a  variable in this study, only variation among  lots