LetsGetChecked Coronavirus (COVID-19) Home Sample Collection Test (CRVSNH)
Primary DI
00860002028095
Brand
LetsGetChecked Coronavirus (COVID-19) Home Sample Collection Test (CRVSNH)
Company
PRIVAPATH DIAGNOSTICS LIMITED
Model
NO05S
Catalog number
NO05S
Device description
The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit is a direct to consumer product for testing of anterior nasal swab specimens collected at home using the LetsGetChecked Coronavirus (COVID-19) Home Collection Kit by any individuals, age 18 years and older (self-collected), 12 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance) including individuals without symptoms or other reasons to suspect COVID-19. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit enables the at-home collection of an anterior nasal swab sample that is then transported to a laboratory designated by LetsGetChecked, Inc. for TMA testing for SARS-CoV-2 with the LetsGetChecked Coronavirus (COVID-19) Test without prescription. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit may be available direct to consumer (DTC) without a prescription at a physical retail location and online direct to consumer. Activation can only be completed by an adult. When a minor is using the kit, it is activated in a sub-account of the adult. Customers cannot create a sub-account for an infant (
A collection of devices intended to be used by a layperson in the home to self-collect and mail a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen to a clinical laboratory for in vitro diagnostic investigation (e.g., COVID-19 testing); it may in addition be used in a clinical setting by a healthcare professional. It consists of a non-suctioning specimen sampling/collection tool(s) [e.g., swab, brush, saliva collection mouthpiece/funnel], a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)], and mailing packing/envelope. This is a single-use device.