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immunoassayReagents

INTENDED USE The Finecare™ One Step cTn I/CK-MB/Myo Rapid Quantitative Test a fluorescence immunoassay to be used along with Finecare™ FIA System for quantitative determination of cardiac Troponin I (cTn I), MB Isoenzyme of Creatine Kinase (CK-MB) and Myoglobin (Myo) in human whole blood, serum or plasma. The test is used as an aid to the diagnosis of myocardial infarction. STORAGE AND STABILITY 1. Store Finecare™ One Step cTn I/CK-MB/Myo Rapid Quantitative Test at 4 ℃~30 ℃. Do not freeze. Shelf life is up to 24 months, refer to label for expiration date 2. If removed from refrigeration, allow the Test Cartridge for 30 minutes to reach room temperature (25±2℃) before testing. 3. Once opened, commence to use the Test Cartridge within an hour. 4. Do not remove the device from the pouch until ready to use. Keep the Test Cartridges away from light.

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Rapid Test

The OnSite Troponin I Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma or whole blood at a level equal to or higher than 1 ng/mL. It can be performed within 15 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite Troponin I Combo Rapid Test is intended to be used by healthcare professionals as an aid in the diagnosis of acute myocardial infarction (AMI). Any use or interpretation of this preliminary test result must also rely on patient’s symptoms and the professional judgment of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device. Normally the level of cTnI in the blood is very low. cTnI is released into the blood stream in forms of free cTnI and cTnI-C-T complex at 4-6 hours after myocardial cell damage. The elevated level of cTnI could be as high as 50 ng/mL during 60-80 hours after AMI and remains detectable for up to 10-14 days post AMI. Therefore, circulating cTnI is a specific and sensitive marker for AMI. Clinical performance: Relative Sensitivity: 95.8% (95% CI: 91.5-97.9%) compared to a reference CLIA Relative Specificity: 99.7% (95% CI: 98.8-99.9%) Analytical sensitivity: The detection limit of cTnI is 1.0 ng/mL or greater in serum, plasma or whole blood specimen Cross-reactivity: No cross reactivity with 10 µg/mL skeletal muscle TnI, 2,000 ng/mL cardiac muscle TnT, 20 µg/mL cardiac muscle Myosin Dose hook effect: No hook effect was observed for cTnI at concentrations up to 3,521 µg/mL Interference: No interference was seen with 20 mg/dl Acetaminophen, 20 mg/dl Acetylsalicylic acid, 10.5 g/dl Albumin, 20 mg/dl Ascorbic acid, 1,000 mg/dl Bilirubin, 20 mg/dl Caffeine, 800 mg/dl Cholesterol, 200 mg/dl Creatinine, 20 mg/dl Gentistic acid, 1,000 mg/dl Hemoglobin, 600 mg/dl Oxilic acid, 1,600 mg/dl Triglycerides Shelf life: 24 months Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample diluent (REF SB-R3002, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Insert MedlinePlus: Troponin Test Poster

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Glucometer

STANDARD CodeFree Plus SD Codefree plus is an easy and simple blood glucose monitor that intuitively tells the user if the blood glucose level is low, on target or high with LED light and beep sound. Advantage Intuitive notification of result with LED light and beep sound No coding SD CodeFree test strips can be shared with other devices Specification Enzyme Glucose Oxidase biosensor Measurement Range 10 - 600mg/dL (0.6 - 33.3 mmol/L) Test Time 5 sec Sample Volume 0.9 µl Hematocrit 20 - 60% Unit mg/dL Memory Up to 100 tests Battery 3V battery (CR2032) Interpretation of results Cat. No. Product Component Note 01GC50 STANDARD™ CodeFree® Plus Blood Glucose Monitoring System Meter, Test Strip (10EA) / Lancet(10EA) / Lancing Device / Check Strip 01GS50 STANDARD™ CodeFree® Plus Blood Glucose Test Strip STANDARD™ CodeFree® Plus Test Strip (25EA x 2 bottle)

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Glucometer

SD CodeFree A representative model of of SD BIOSENSOR which is easy to use and provides accurate results without the need for coding. The SD Codefree Blood Glucose Meter is a compact, hand-held, and easy-to-read monitor that stores up to 500 test results. It provides an accurate picture of your blood glucose level at the time of the test from a small droplet of blood. Specification Enzyme Glucose Oxidase biosensor Measurement Range 10 - 600mg/dL (0.6 - 33.3 mmol/L) Specimen volume 5 sec Sample Volume 0.9 µl Hematocrit 20 - 60% Unit mg/dL Memory Up to 500 tests Battery 3V battery (CR2032) Interpretation of results Cat. No. Product Component Note 01GC110 SD CodeFree™ Blood Glucose Monitoring System Meter, Test Strip (10EA) / Lancet(10EA) / Lancing Device / Check Strip 01GS11 SD CodeFree™ Blood Glucose Test Strip SD CodeFree™ Test Strip (25EA x 2 bottle)

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Glucometer

FREESTYLE LIBRE PRO Flash Glucose Monitoring System Product Description FreeStyle Libre Pro is clinician's glucose assessment tool that redefines easy. FreeStyle Libre Pro is for the use by Healthcare Professionals only. Easy for patients. Convenient and scalable for clinic. FreeStyle Libre Pro Sensor Small and discreet The FreeStyle Libre Pro sensor is applied on the back of the upper arm. The sensor is water resistant1. Very thin filament Filament is <0.4 mm thick and inserted 5 mm beneath the skin surface to measure glucose levels. Up to 14 days of data Automatically records glucose level every 15 minutes to provide more insightful patterns. Data is blinded from the patient No patient interaction with the sensor is required — designed to integrate with patients' daily lives. FreeStyle Libre Pro Reader The reader stays in the clinic No need to worry about patients losing or damaging components. One reader device starts multiple patients Multiple patients per reader minimizes waiting time and scheduling issues. Lower costs for the clinic The need for only one reader device can help lower your clinic expenses. FreeStyle Libre Pro is an innovative sensor-based ‘Flash Glucose Monitoring’ device that captures glucose readings every 15 minutes for up to 14 days, and gives complete glucose profile report in the form of 'Ambulatory Glucose Profile'. Daily Patterns with Ambulatory Glucose Profile AGP offers a standardized visualization of glucose data that is reliable, predictive, and actionable. The glucose data, generated by Flash Glucose Monitoring over several days or weeks, are collapsed into a single 24-hour period, creating a view of a modal day. This view reveals underlying patterns in glucose variability to a greater extent than using HbA1c by itself. AGP allows healthcare professionals to more effectively visualize and utilize glucose data in the clinical management of diabetes. AGP identifies areas of hyperglycemia, hypoglycemia and glucose variability. Daily Glucose Summary With ‘Daily Glucose Summary’ report, it is easier to know patient’s ‘Time in Target’ Product Specification Model Name/Number Freestyle Libre Pro Averages 14 Days Result Time 3 sec Display LCD Memory Capacity 500 test results Power Supply 1 battery (type CR2032) Sample Type Peripheral Capillary Whole Blood/Venous Whole Blood Weight 45g Including Battery Hematocrit Range 50% Minimum Order Quantity 5 Piece

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Glucometer

FreeStyle Freedom Lite Blood Glucose Monitoring System, Results in Just 5 sec. Abbott FreeStyle Freedom Lite Blood Glucose Monitoring System with a new ergonomic shape and the large numeric display is ideal for those looking for simple and accurate testing. It requires the world's smallest blood sample size and features no-code technology for total ease of testing. Small blood sample size. Fast 5 second average test time. Four programmable alarms remind patients when to test.60-second sample replication time and fill-trigger prevent test from starting without an adequate blood sample. Four daily programmable alarms to remind you when it's time to test. Easy to read, large numeric display Easy to hold, large comfortable design No coding, means one less step Small sample size, only 0.3 microliter Fast, 5-second average test time Contents include: Free Style Freedom Lite Blood Glucose Meter, 1 Lancing Device, 10 Lancets, Carrying Case, English/Spanish Owner's Booklet For use with Free Style Lite test strips only, sold separately

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Glucometer

Product Name: FreeStyle Freedom Lite 100 Test Strips FreeStyle Lite test strips are specially designed for fast, easy testing and are intended to be used with FreeStyle Lite and FreeStyle Freedom Lite blood glucose monitoring systems only. Our patented ZipWik tabs break the surface of the blood sample for instant wicking action. Plus, there’s no coding required. Easy to Use · Patented ZipWik tabs target blood sample for easy application and fast uptake · No coding required means one less step Product Specification Minimum Order Quantity 1 Pack Product Description Product Name: FreeStyle Freedom Lite 100 Test Strips FreeStyle Lite test strips are specially designed for fast, easy testing and are intended to be used with FreeStyle Lite and FreeStyle Freedom Lite blood glucose monitoring systems only. Our patented ZipWik tabs break the surface of the blood sample for instant wicking action. Plus, there’s no coding required. Easy to Use · Patented ZipWik tabs target blood sample for easy application and fast uptake · No coding required means one less step Proven accuracy Patented ZipWik Tabs · Greater accuracy versus OneTouch Ultra2 and Contour systems1 · Minimizes interference from 22 common substances2 Minimizes Wasted Test Strips · Up to 60 seconds to reapply blood · Smallest sample size – uses just one-third the blood of OneTouch Ultra3 Contents: 2 x 50 Test Strips

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Glucometer

Product Specification Model Name/Number Abbott Freestyle Optium NEO H Glucometer Usage/Application Clinic Box Contents Meter -1 No Averages 7 Days Result Time 5 sec Display LED Sample Volume 1 ul Battery Life 1000 Product Description Features 1. No coding features makes for easy testing 2. AST (Alternate Site Testing) to test on areas other than your fingertip. 3. Small blood sample required for blood glucose testing- 0.6µL 4. 5-second test time for glucose testing. 5. Display light to assist in low light testing. 6. Large screen for clear and easy to read results. 7. Icon driven menu makes it easy to view results 8. Displayed averages of 7, 14 and 30 days. 9. Large memory of 450 events.

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