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About Us and Our Rapid Test Kits

QUALITY AND ACCURACY

Test Kits are 98-99% accurate in detection of sexually transmitted infection. Our Medical Test Kits are manufactured under strict quality controls. Most importantly the ISO 13485 Medical Device Standard

The ISO 13485 Medical Device Standard

ISO 13485 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices. Certification to ISO 13485 requires its quality system to pass a third-party Medical Device Single Audit Program, or “MDSAP” audit. ISO 13485 is recognized by WHO and FDA.

You can read more about ISO 13485 here https://en.wikipedia.org/wiki/ISO_13485

What ISO 13485 means to the consumer:

Consumers can purchase products carrying the ISO 13485 standard knowing that the design and manufacturing process is legally compliant and meets quality management assurance. Additionally, the manufacturing plant is inspected annually by ISO staff.