Certificates
  • China Guangzhou Decheng Biotechnology Co.,LTD certification
    Standard: FDA 510k
    Number: K222305
    Issue Date: 2022-11-30
    Expiry Date:
  • China Guangzhou Decheng Biotechnology Co.,LTD certification
    Standard: ISO 13485
    Number: No.Q5 110530 0001 Rev.00
    Issue Date: 2022-03-16
    Expiry Date: 2025-03-15
  • China Guangzhou Decheng Biotechnology Co.,LTD certification
    Standard: CE for self test
    Number: No. V1 110530 0002 Rev.00
    Issue Date: 2022-03-16
    Expiry Date: 2025-05-26
  • China Guangzhou Decheng Biotechnology Co.,LTD certification
    Standard: MDSAP
    Number: CN23/00001911
    Issue Date: 2023-04-14
    Expiry Date:
QC Profile

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.