Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical

Sexually transmitted infection (STI) testing specimen collection kits are medical devices designed for professional use to collect clinical specimens at the point-of-care for subsequent diagnostic testing of STIs. These kits contain various collection tools and transport containers, with or without additives, to ensure proper sample handling and preservation.

These devices are typically single-use and intended exclusively for professional healthcare settings. They are regulated as in vitro diagnostic devices and must meet specific requirements for safety and effectiveness in collecting specimens for STI testing.