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The Flowflex Plus COVID-19 + Flu A/B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath should therefore seek follow-up care from their healthcare provider. Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

The Flowflex Plus COVID-19 + Flu A/B Home Test is a lateral flow immunoassay.

The Distinct® Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid for the early detection of pregnancy. This test can help determine if you are pregnant as early as 6 days before the day of the missed period (5 days before the day of your expected period).

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The Flowflex Plus COVID-19 Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID 19 within the first 6 days of symptom onset. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. The Flowflex Plus COVID-19 Home Test does not differentiate between SARS-CoV and SARS-CoV-2. All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider. The performance characteristics for SARS-CoV-2 were established during June 2022 to April 2023 when COVID-19 variant Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

The Flowflex Plus COVID-19 Home Test is a visually read lateral flow immunoassay device.

The Flowflex COVID-19 Antigen Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 within the first 6 days of symptom onset. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. The Flowflex COVID-19 Antigen Home Test does not differentiate between SARS-CoV-2. All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider. The performance characteristics for SARS-CoV-2 were established from December 2022 to March 2023 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

The Flowflex COVID-19 Antigen Home Test is a visually read lateral flow immunoassay device.

The Distinct® Early Detection Pregnancy Test is an aid for the early detection of pregnancy intended for home use. The device is a chromatographic immunoassay that performs qualitative detection of human chorionic gonadotropin (hCG) in urine. This test can help determine pregnancy as early as 6 days before the day of the missed period (5 days before the day of the expected period).

The Distinct® Early Detection Pregnancy Test is a rapid chromatographic immunoassay for in vitro qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. It is for self-testing. The test strip and absorbent tip are assembled in a plastic housing. The test strip contains monoclonal anti-hCG antibodies and goat anti-mouse polyclonal antibodies. The test result is shown in the result window and read visually after 3 minutes of urine application. A blue sign of plus (+) at the test window indicates that hCG has been detected (pregnant). Absence of the plus (+) and only a blue line (-) in the Test Window suggests no hCG has been detected. To serve as a procedural control, a blue line will always appear in the Control Window indicating that proper volume of specimen has been added and membrane wicking has occurred.

The On Call® Express II Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steady-state times (when blood glucose level is not changing rapidly). The On Call® Express II Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only. The On Call® Express II Blood Glucose Monitoring System is not intended for the diamosis of or diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call® Express II Blood Glucose meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

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The On Call® Express Voice Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steadystate times (when blood glucose level is not changing rapidly). The On Call® Express Voice Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only. The On Call® Express Voice Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

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The On Call Sure Blood Glucose Monitoring System is comprised of the On Call Sure Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Blood Glucose Monitoring System is intended to the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Blood Glucose Monitoring System is intended for single-patient use and should not be shared. The On Call Sure Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The On Call Sure Sync Blood Glucose Monitoring System is comprised of the On Call Sure Sync Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Sync Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Sync Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Sync Blood Glucose Monitoring System is intended for single-patient use and should not be shared. The On Call Sure Sync Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Sync Blood Glucose Monitoring System is not intended for the diagnosis of or diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System are designed for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm, and/or palm. Both systems have almost the same meter design and use the same strip and control solution. The only difference is that On Call Sure Sync Blood Glucose meter is embedded with a Bluetooth module which results in an additional Bluetooth data transfer feature for this meter. Thus, the On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System can be considered equivalent for the performance of glucose testing. Both systems share the same On Call Sure Blood Glucose test strip. It has a reagent system that includes glucose dehydrogenase (FAD-GDH) and a mediator that reacts with the glucose in the whole blood sample to produce an electrical current signal. This current is measured using an amperometric detection method. The meter then calculates and displays the blood glucose concentration reading, calibrated to plasma reference. The On Call Sure / On Call Sure Sync Blood Glucose Meters are auto-coding. Both systems consist of the On Call Sure / On Call Sure Sync Blood Glucose Meter, On Call Sure Blood Glucose Test Strips, and On Call Sure Clucose Control Solutions. Kits may be marketed with various combinations and quantities of the system components, or each of the components may be sold separately. All meter kits include a Carrying Case, User's Manual, Ouick Reference Guide, Warranty Card and Logbook. Materials needed but not provided include a single user lancing device and sterile lancets. The On Call Sure Glucose Control Solutions are used to confirm that the meter and test strips are working properly. Glucose control solution(s) is/are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. Two control solution levels are available (Level 1 and Level 2). Level 1 is provided with the system. Level 2 is sold separately. Both meters have a USB data transfer function that is inactive, pending validation with the On Call Diabetes Management Software (K131469). Only the On Call Sure Sync Blood Glucose Meter is equipped with Bluetooth. The On Call Sure Sync Blood Glucose Meter is designed with a Bluetooth module which can send glucose test results to a mobile device if the glucose meter and the mobile device are paired and within range.

The Mission® Lipid Panel Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingerin venous whole blood. The Mission® Lipid Panel Monitoring System consisting of the Mission® Lipid Panel Meter, Mission® Lipid Panel Test Cartridges, Mission® Cholesterol Optical Verifier, and Mission® Cholesterol Control Solution, and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto disabling lancing devices. This system is for in vitro diagnostic use only. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (High Density Lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders. An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Pro Meter and is reported only when Triglycerides are ≤400 mg/dL.

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The On Call® Express Mobile Blood Glucose Monitoring System is intended to be used for the quantitative detection of glucose in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly) The On Call® Express Mobile Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only. The On Call® Express Mobile Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call® Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

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