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:
• 
  Standard: BRC

  Number: CN23/00003165

  Issue Date: 2023-05-25

  Expiry Date: 2024-07-06

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 batches and different batches: standard or quality control products will be used to test each batch of products.