Standard: FDA 510kNumber: K222305Issue Date: 2022-11-30Expiry Date:
Standard: ISO 13485Number: No.Q5 110530 0001 Rev.00Issue Date: 2022-03-16Expiry Date: 2025-03-15
Standard: CE for self testNumber: No. V1 110530 0002 Rev.00Issue Date: 2022-03-16Expiry Date: 2025-05-26
Standard: MDSAPNumber: CN23/00001911Issue Date: 2023-04-14Expiry Date:
QC of raw materials, including antigen, antibody, colloidal gold, NC membrane etc.
Validation before manufacturing
Optimization and validation in manufacturing process
Validation before packaging of finished product and accelerated life testing
Third Party Sampling Validation after packaging
Sampling testing for kits from same batch and different batches: use a number of different negative samples and samples after addition of different levels of standards for testing to control within and between batch disparity.