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Why Can We Always Ensure Excellent Quality

Quality Control

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.

Certification

Guangzhou Decheng Biotechnology Co.,LTD Certifications
Standard: FDA 510k
Number: K222305
Issue Date: 2022-11-30
Scope/Range: Digital pregnancy test
Issued By: US FDA
Guangzhou Decheng Biotechnology Co.,LTD Certifications
Standard: ISO 13485
Number: No.Q5 110530 0001 Rev.00
Issue Date: 2022-03-16
Expiry Date: 2025-03-15
Scope/Range: Digital pregnancy/ovulation test
Issued By: TUV
Guangzhou Decheng Biotechnology Co.,LTD Certifications
Standard: CE for self test
Number: No. V1 110530 0002 Rev.00
Issue Date: 2022-03-16
Expiry Date: 2025-05-26
Scope/Range: Digital pregnancy/ovulation test
Issued By: TUV
Guangzhou Decheng Biotechnology Co.,LTD Certifications
Standard: MDSAP
Number: CN23/00001911
Issue Date: 2023-04-14
Scope/Range: All Dochek's products
Issued By: SGS
Guangzhou Decheng Biotechnology Co.,LTD Certifications
Standard: BRC
Number: CN23/00003165
Issue Date: 2023-05-25
Expiry Date: 2024-07-06
Scope/Range: All Dochek's products
Issued By: SGS
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