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Intended to be used for the qualitative detection of RNA from SARS-CoV-2
Low profile 96 well PCR plated assay and optical film for use on Roche LightCycler 11 instrument .
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution
- 05060654860059 ()
- 05060654860134 ()
ID-CoV2-01-LPU
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Single-use Face Mask
Soft & Easy to Breath
Use as Surgical Mask
BYD Precision Manufacture Co., Ltd.
FF1311
In Commercial Distribution
- 00860003624807 ()
- Area/Surface Area: 25.77 Square inch
FF1311
- Surgical/examination garment kit
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
25pcs 1st aid kit
Shenzhen Intra Industry Co., Ltd.
FAK25
In Commercial Distribution
- 06941987130059 ()
25
- First aid kit, medicated
D C TRAY
Cardinal Health 200, LLC
SMA33DCRS4
In Commercial Distribution
- 50195594289711 ()
- 10195594289713 ()
SMA33DCRS4
- Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
No Description
Shenzhen Yurucheng Dental Materials Co., Ltd.
ML-BL2-3D
In Commercial Distribution
- 06942053528664 ()
3DPlus 95×10mm
- Dental appliance fabrication material, ceramic
No Description
Shenzhen Yurucheng Dental Materials Co., Ltd.
ML-C3-3D
In Commercial Distribution
- 06942053526424 ()
3DPlus 95×12mm
- Dental appliance fabrication material, ceramic
No Description
Shenzhen Yurucheng Dental Materials Co., Ltd.
ML-C1-3D
In Commercial Distribution
- 06942053526042 ()
3DPlus 89×71×20mm
- Dental appliance fabrication material, ceramic
No Description
Shenzhen Yurucheng Dental Materials Co., Ltd.
BL1
In Commercial Distribution
- 06942053511161 ()
UT 95×10mm
- Dental appliance fabrication material, ceramic
D AND C PACK
Cardinal Health 200, LLC
SMA4LDCGRE
In Commercial Distribution
- 50195594308368 ()
- 10195594308360 ()
SMA4LDCGRE
- Obstetrical/gynaecological surgical procedure kit, medicated