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The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.

The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.

Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R138) Montana Jack™ (R223) 23 Explorer-12 Probe (R245) Cone Socket Mirror Handle (R269) 3-6 Discoid-Cleoid Carver (R284) Hollenback 1/2-3 Carver (R286) G2 Thin Composite (R287) G3 Thin Composite (R333) 27-29 Burnisher (R336) Calcium Hydroxide Placer (R347) 0-1 Blacks Plugger (R362) 113 Off Angle Cord Packer (R375) Mixing Spatula-Applicator (R386) 38-39 Excavator (R534) IPC-T Gold Line™ (Composite Sculpting System) (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T356) Amalgam Well (T800) Iris Curved Scissors (11.5cm)

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.

Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software. The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica’s Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips’ Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips’ Ultra Fast Scanner and Philips PP27QHD monitor.

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Skullerz DELLENGER Enhanced Anti-Fog & Scratch-Resistant Safety Glasses feature adjustable temples that shift up or down and lock into place for a custom fit on a variety of face sizes. These safety glasses feature tough anti-scratch and anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. The rimless design makes for a lightweight and comfortable fit and maximizes a full field of vision. A contoured nose bridge won’t slip or pinch and the flex-fit temples reduce pressure and provide stay-put all-day comfort.

Skullerz DELLENGER Enhanced Anti-Fog & Scratch-Resistant Safety Glasses feature adjustable temples that shift up or down and lock into place for a custom fit on a variety of face sizes. These safety glasses feature tough anti-scratch and anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. The rimless design makes for a lightweight and comfortable fit and maximizes a full field of vision. A contoured nose bridge won’t slip or pinch and the flex-fit temples reduce pressure and provide stay-put all-day comfort.

Skullerz DELLENGER Enhanced Anti-Fog & Scratch-Resistant Safety Glasses feature adjustable temples that shift up or down and lock into place for a custom fit on a variety of face sizes. These safety glasses feature tough anti-scratch and anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. The rimless design makes for a lightweight and comfortable fit and maximizes a full field of vision. A contoured nose bridge won’t slip or pinch and the flex-fit temples reduce pressure and provide stay-put all-day comfort.

Skullerz DELLENGER Anti-Fog Safety Glasses feature adjustable temples that shift up or down and lock into place for a custom fit on a variety of face sizes. These safety glasses feature tough anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. The rimless design makes for a lightweight and comfortable fit and maximizes a full field of vision. A contoured nose bridge won’t slip or pinch and the flex-fit temples reduce pressure and provide stay-put all-day comfort.