Final product manufacture and qc record for cov1120207.No abnormal issue was found in manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with dmr.The test results of retention samples from cov1120207 can meet the qc criteria.We have not found the complaint issue from the retained cassettes.The complaint is not verified.In this follow-up report, the following information has been updated from the initial report upon completion of the internal.Investigation.The following fields are updated: b4, "date of this report" - date of follow-up report.G6, "type of report" - follow-up #1.H2, "if follow-up, what type?" - updated to "additional information" and "device evaluation".H6 "adverse event problem" - event problem and evaluation codes such as "investigation findings" and "investigation.Conclusions" are added per investigation.H10 "additional narrative/data" - added manufacturer's narrative.
|