Which system certification is needed to produce type 3 IVD (PCR kit), namely ISO 13485 or ISO 15 189 or both?

Medical device manufacturers are generally ISO 13485 or ISO900 1. I am familiar with several IVD manufacturers, such as ISO13485 (+ISO 9001), Shanghai Zhicheng Bio, Beijing Jiuqiang, Lidman and Sichuan Mike. And ISO 13488.