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The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data. For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.

The InPen System consists of a manually-controlled pen injector and an app containing a logbook and a dose (bolus) calculator. The InPen is a manual pen injector containing a non-replaceable battery and electronics to communicate via Bluetooth® with the app on an iOS® mobile device. The intended dose is manually set by the user by rotating a dose knob. The insulin is injected by manually depressing the dose knob which causes the piston in the insulin cartridge to expel the intended dose. The InPen is provided in two different models for compatibility with the available U-100 insulin cartridges, i.e. Humalog®, Novolog®, and Fiasp®. The device is provided with Instructions For Use and a Quick Start Guide. The device is used with sterile needles and U-100 insulin cartridges (supplied separately). The app is designed to manage the wireless transfer of insulin dose data from the InPen, log insulin dose data, and provide a dose calculator to aid mealtime insulin dose calculations. The insulin dose calculations provided by the app are meant for patients undergoing multiple daily injection (MDI) therapy. The InPen app is not intended to serve as an accessory to an insulin pump.

The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. The device is indicated for use with NovoLog® or Humalog® U-100 insulin. For an insulin dose based on amount of carbohydrates, a healthcare provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/ meal sizes to be programmed into the software prior to use.

The InPen app is designed to manage the wireless transfer of insulin dose data from the InPen, log insulin dose data, and provide a dose calculator to aid mealtime insulin dose calculations. The insulin dose calculations provided by the app are meant for patients undergoing multiple daily injection (MDI) therapy. The InPen app is not intended to serve as an accessory to an insulin pump.

The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.

The InPen System consists of a manually-controlled pen injector and an app containing a logbook and a dose (bolus) calculator. The InPen is a manual pen injector containing a non-replaceable battery and electronics to communicate via Bluetooth® with the app on an iOS® mobile device. The intended dose is manually set by the user by rotating a dose knob. The insulin is injected by manually depressing the dose knob which causes the piston in the insulin cartridge to expel the intended dose. The InPen is provided in two different models for compatibility with the available U-100 insulin cartridges, i.e. Humalog®, Novolog®, and Fiasp®. The device is provided with Instructions For Use and a Quick Start Guide. The device is used with sterile needles and U-100 insulin cartridges (supplied separately). The app is designed to manage the wireless transfer of insulin dose data from the InPen, log insulin dose data, and provide a dose calculator to aid mealtime insulin dose calculations. The insulin dose calculations provided by the app are meant for patients undergoing multiple daily injection (MDI) therapy. The InPen app is not intended to serve as an accessory to an insulin pump.

Vstrip® H.pylori Antigen Rapid Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. Test results are intended to aid in the initial diagnosis and treatment of H. pylori infection. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.

The Vstrip® H.pylori Antigen Rapid Test (Vstrip®) is a Helicobacter pylori (H. pylori) antigen rapid test. It is a lateral flow immunochromatographic assay which employs antibody-coated latex beads to detect H. pylori antigens in stool specimens from patients suspected of H. pylori infection. This test is an in vitro diagnostic device to be used for the qualitative detection of H. pylori antigen in human stool samples, and test results are intended to aid in the diagnosis and treatment of H. pylori infection. This test utilizes a pair of H. pylori-specific monoclonal antibodies that are capable of detecting H.pylori antigens in human stool. The assay kit includes a foil pouch containing test cassette which houses a strip incorporated with a pair of H. pylori-specific monoclonal antibodies, sample preparation tubes that contain sample diluent buffer for dilution of stool sampler tool attached to the underside of the tube cap and a dispenser tool attached to the top of the tube, positive control reagent containing inactivated H.pylori, and the package insert and instructions. Each diagnostic strip is enclosed in a plastic frame with a window to display the results. To perform the test, a diluted stool sample which is first prepared by a sample preparation tube is added to the Test Cassette. If the sample contains H.pylori antigen, a pink-red test to the letter T) along with a blue control line (next to the letter C) will be visible in the rectangle "Result Window", as depicted in Figure 1. A blue control line is a line to show that adequate flow of the sample has occurred and active components have been employed during a test run. The presence of the blue line at the control position on the device confirms that the device is working properly. If H. pylori antigen is absent or below the level of detection, no pink-red line will appear in the rectangle "Result Window" of the cassette next to the letter T, but a distinct blue line shows next to the letter C, as depicted in Figure 1. For invalid result, no visible blue line in the rectangle "Result Window" of the cassette next to the letter C, with or without a visually detectable pink-red line, as depicted in Figure 1. It may occur with the deteriorated materials, but an excess of stool sample and incorrect procedure is mostly the main reason for control line failure. When an invalid result appears, review the test procedure and re- test same specimen. If the test fails again, repeat the test with different specimens. If the problem persists, the use of concerned test kit lot should be discontinued.

The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.

The InPen app is designed to manage the wireless transfer of insulin dose data from the InPen, log insulin dose data, and provide a dose calculator to aid mealtime insulin dose calculations. The insulin dose calculations provided by the app are meant for patients undergoing multiple daily injection (MDI) therapy. The InPen app is not intended to serve as an accessory to an insulin pump.

The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges of insulin and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Novo Nordisk Novolog® U-100 3.0 mL cartridges of insulin and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.

The InPen System consists of a manually-controlled pen injector and an app containing a logbook and a dose (bolus) calculator. The InPen is a manual pen injector containing a non-replaceable battery and electronics to communicate via Bluetooth® with the app on an iOS® mobile device. The intended dose is manually set by the user by rotating a dose knob. The insulin is injected by manually depressing the dose knob which causes the piston in the insulin cartridge to expel the intended dose. The InPen is provided in two different models for compatibility with the available U-100 insulin cartridges, i.e. Humalog® and Novolog®. The device is provided with Instructions For Use and a Quick Start Guide. The device is used with sterile needles and U-100 insulin cartridges (supplied separately). The app is designed to manage the wireless transfer of insulin dose data from the InPen, log insulin dose data, and provide a dose calculator to aid mealtime insulin dose calculations. The insulin dose calculations provided by the app are meant for patients undergoing multiple daily injection (MDI) therapy. The InPen app is not intended to serve as an accessory to an insulin pump.