Guangzhou Decheng Biotechnology Co.,LTD Quality Control

• 
  Standard: FDA 510k

  Number: K222305

  Issue Date: 2022-11-30

  Expiry Date:
• 
  Standard: ISO 13485

  Number: No.Q5 110530 0001 Rev.00

  Issue Date: 2022-03-16

  Expiry Date: 2025-03-15
• 
  Standard: CE for self test

  Number: No. V1 110530 0002 Rev.00

  Issue Date: 2022-03-16

  Expiry Date: 2025-05-26
• 
  Standard: MDSAP

  Number: CN23/00001911

  Issue Date: 2023-04-14

  Expiry 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.