Core Viewpoint - The company has received a medical device registration certificate from the Guangdong Provincial Drug Administration for its total bilirubin assay kit, indicating a significant regulatory milestone for the product [1] Group 1 - The total bilirubin assay kit (using the diazo method) is designed for the quantitative measurement of total bilirubin (TBIL) concentration in human serum or plasma, including newborns [1] - The kit is primarily used as one of the evaluation indicators for bilirubin metabolism disorders in clinical settings [1]