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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 (<2years). LetsGetChecked HCP will contact all individuals receiving positive and invalid test results. Individuals with negative test results will be notified by email, phone message and through the website portal. For purposes of this EUA, a healthcare provider includes any healthcare professional with prescribing abilities including, but not limited to, physicians, nurses, pharmacists, and laboratory directors. The healthcare provider contacting individuals with test results will have prescribing privileges for that individual, should medication be indicated for treatment.
PRIVAPATH DIAGNOSTICS LIMITED
NO14S, NO15S, NO05S
In Commercial Distribution
- 00860002028095 ()
- Oral/upper respiratory tract specimen collection kit IVD, home-use
DRIVER 9098061 HEX STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
9098061
In Commercial Distribution
- 00681490993616 ()
- Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
31-476946
In Commercial Distribution
- 00880304008984 ()
31-476946
- Orthopaedic implant driver
INSTRUMENT 8951808 18MM DRIVER SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
8951808
In Commercial Distribution
- 00681490907149 ()
- Orthopaedic implantation sleeve, reusable
T-HANDLE W/ MINI HUDSON QC
MEDTRONIC SOFAMOR DANEK, INC.
X0101012
In Commercial Distribution
- 00681490906753 ()
- Orthopaedic implant driver
INSTRUMENT 8950003 TAPRD IMP DRVR WRENCH
MEDTRONIC SOFAMOR DANEK, INC.
8950003
In Commercial Distribution
- 00681490904810 ()
- Orthopaedic implant driver
INSTRUMENT 8950001 DBL DISTRCTR DRVR CAP
MEDTRONIC SOFAMOR DANEK, INC.
8950001
In Commercial Distribution
- 00681490904803 ()
- Orthopaedic implant driver
DRIVER 8001205 MOD SHAFT 1.6MM
MEDTRONIC PS MEDICAL, INC.
8001205
In Commercial Distribution
- 00681490904384 ()
- General internal orthopaedic fixation system implantation kit
DRIVER 8001201 HANDL MOD TIMESH
MEDTRONIC PS MEDICAL, INC.
8001201
In Commercial Distribution
- 00681490904360 ()
- General internal orthopaedic fixation system implantation kit
M8 MAS DRIVER W/ BALL DETENT
MEDTRONIC SOFAMOR DANEK, INC.
X1000007
In Commercial Distribution
- 00681490902250 ()
- Orthopaedic implant driver