Device for home collection and transport of vaginal specimens by lay users for use in an approved hpv molecular assay / System for detection of nucleic acid from non-viral microorganism(s) causing stis using specimens collected at home

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Product	Model	Company	Device type
BD Molecular Swab Collection KitBecton, Dickinson and CompanySexually transmitted infection (STI) testing specimen collection kit IVD, clinical	443925	Becton, Dickinson and Company	Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
Color Cervical Cancer ScreeningColor Diagnostics, LLCSexually transmitted infection (STI) testing specimen collection kit IVD, home-use	1.0	Color Diagnostics, LLC	Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use
Onclarity™ Self-Collection Kit (HPVX)Privapath Diagnostics LimitedSexually transmitted infection (STI) testing specimen collection kit IVD, home-use	VS01S	Privapath Diagnostics Limited	Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use
simpli-COLLECTAbbott Molecular Inc.General specimen container IVD, no additive/medium	09R02-001	Abbott Molecular Inc.	General specimen container IVD, no additive/medium
simpli-COLLECTAbbott Molecular Inc.General specimen container IVD, no additive/medium	09N93-001	Abbott Molecular Inc.	General specimen container IVD, no additive/medium
Xpert®CepheidGeneral specimen collection kit IVD, clinical	SWAB/G-50-US	Cepheid	General specimen collection kit IVD, clinical