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immunoassayReagents

INTENDED USE The Finecare™ β2-MG Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of β2-MG (Beta-2-Microglobulin) concentration in human plasma, serum or whole blood. The test is used as an aid for the diagnosis of renal disease. STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

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Rapid Test

The OnSite Duo HSV-1/2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. This test can be performed in 10 minutes by minimally skilled personnel without the use of laboratory equipment. This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with HSV-1 and/or HSV-2. The OnSite Duo HSV-1/2 IgG/IgM Rapid Test uses HSV-1 glycoprotein G1 and HSV-2 glycoprotein G2 for the specific detection and differentiation of IgG and IgM antibodies to HSV-1 and HSV-2 in serum, plasma and whole blood. An HSV-1 and/or HSV-2 IgM positive result indicates an active infection, which may be primary or recurrent. An HSV-1 and/or HSV-2 IgG positive result indicates a recent or past infection. However, a negative test result does not preclude the possibility of infection with HSV-1 and/or HSV-2. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device. Clinical accuracy: 90.6% sensitivity and 91.4% specificity for anti-HSV-1 IgG detection 93.8% sensitivity and 96.0% specificity for anti-HSV-2 IgG detection 85.0% overall agreement for anti-HSV-1 IgM detection comparing to commercial ELISA 100% overall agreement for anti-HSV-2 IgM detection comparing to BBI Panel (PTH202) Positive rate on random clinical specimens:8% for IgG anti-HSV-1 and 4.9% for IgM anti-HSV-1 (n=10,000); 4.6% for anti-HSV-2 IgG and 1.7% for anti-HSV-2 IgM Cross reactivity: no cross reactivity with the following disease states or special conditions, respectively: palladium, H. pylori, Dengue, Malaria, Typhoid, Toxoplasma, Rubella, CMV, hCG, TB, HAV, HBV, HCV, HEV, HIV, ANA, HAMA, RF (up to 1,000 IU/mL) Interference: No interference was seen with Albumin 60 g/L , Hemoglobin 2 g/L, Bilirubin 20 mg/dL, Heparin 3,000 U/L, Creatinine 442 µmol/L, Salicylic acid 4.24 mmol/L, EDTA 3.4 µmol/L, Sodium citrate 8%, Glucose 55 mmol/L Shelf life: 24 months Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0203, 5 mL/bottle) Package insert (instruction for use) Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0203, 5 mL/bottle) Package insert (instruction for use)

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Glucometer

The GLUCOCARD Vital is everything a blood glucose meter should be - fast, accurate and easy to use. A small 0.5 µL sample size in our GO-based test strip platform gives accurate results in as little as 7 seconds. This auto coded meter has a 250-test memory, records 14- and 30-day averaging and is downloadable. Sample volume: 0.5 μL Test time: 7 seconds Meter range: 20-600 mg/dL Results: Plasma referenced Calibration: Auto coding Display: LCD Memory: 250 tests with time & date stamp Averaging: 14- and 30-day averaging Downloadable: Yes

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Glycohemoglobin Analysis

Xpress Gluco strips make the testing experience better. These Glucometer strips are designed for self-testing, for both professional and home use. Accurex Blood Glucose test strips provide accurate results in just 5 seconds. Buy Xpress Gluco Test Strips (Pack of 100 Strips) Online from Accurex Point of Care (POC) Diagnostics. The Sugar machine strips do not require any coding & are compatible with Accurex glucometers only. Sample size: 0.5uL, System Measurement Range: 20-800 mg/dL, Hemocrit Range: 25-55 %, Works only with Accurex Glucometer. TEST PRINCIPLE: ELECTROANALYTICALAMPEROMETRY When blood is added to the Xpress Gluco test strip, the chemicals within the strip react with the blood to create a tiny electrical current. Your meter will read that current and display you the blood glucose level. • Accurex test strips make the testing experience better. • Longer shelf life and clearly marked expiry date. • Designed for self testing for both professional and home use. • Accurate results in just 5 seconds. • Works only with Accurex Glucometer. • Uses only 0.5uL blood sample size • Alternate site testing possible • No-coding required • Compatible with Accurex glucometers only CHEMICAL COMPOSITION: Each Xpress Gluco test strip contains: • Enzyme Glucose Oxidase (Aspergillus Sp.) ≥ 1IU • Other ingredients (Mediator, Surfactant, Stabilizing agents etc.) ≥ 200μg • Xpress Gluco Test Strips are used to measure glucose in Capillary whole blood outside of the body (in vitro diagnostic use). • Use Xpress Gluco Test Strips only with the Xpress Gluco Blood Glucose Test System. • Xpress Gluco Test Strips are plasma calibrated to allow easy comparison of results with laboratory methods. • This system is not intended for use in the diagnosis of diabetes mellitus. • This system is not recommended for Neonates Blood samples. Result interpretation: • Xpress Gluco Meter delivers plasma equivalent results and are displayed in mg/dL. • The measurement range of the meter is 20-800mg/dL. • Your blood glucose values will vary due to such things as diet, time of day and what you are doing. Your healthcare professional will help you to understand these variations. You should set your own range of expected blood glucose values, testing times, and discuss your blood glucose results with your healthcare professional. • When blood is added to the Xpress Gluco test strip, the chemicals within the strip react with the blood to create a tiny electrical current. • Your meter will read that current and display you the blood glucose level. • Use fresh whole blood sample only. • Sample size: 0.5uL • Analysis time: 5 seconds • System Measurement Range: 20-800 mg/dL • Hemocrit Range: 25-55 % UNEXPECTED RESULTS: Very high or very low blood glucose readings can indicate a serious medical condition. Repeat the test if you see an unusual reading. If these results are still unusual, or do not match your symptoms, contact your health care professional for advice. Hi or Low readings may indicate hyper or hypoglycemia and should be treated immediately. ABOUT ALTERNATIVE SITE TESTING: Test can be done on alternative site (other than fingertip). However, there are limitations. Please consult your physician before perfoming AST.

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Rapid Test

Xpress Gluco strips make the testing experience better. These Glucometer strips are designed for self-testing, for both professional and home use. Accurex Blood Glucose test strips provide accurate results in just 5 seconds. Buy Xpress Gluco Test Strips (Pack of 10 Strips) Online from Accurex Point of Care (POC) Diagnostics. The Sugar machine strips do not require any coding & are compatible with Accurex glucometers only. Sample size: 0.5uL, System Measurement Range: 20-800 mg/dL, Hemocrit Range: 25-55 %, Works only with Accurex Glucometer. TEST PRINCIPLE: ELECTROANALYTICALAMPEROMETRY When blood is added to the Xpress Gluco test strip, the chemicals within the strip react with the blood to create a tiny electrical current. Your meter will read that current and display you the blood glucose level. • Accurex test strips make the testing experience better. • Longer shelf life and clearly marked expiry date. • Designed for self testing for both professional and home use. • Accurate results in just 5 seconds. • Works only with Accurex Glucometer. • Uses only 0.5uL blood sample size • Alternate site testing possible • No-coding required • Compatible with Accurex glucometers only CHEMICAL COMPOSITION: Each Xpress Gluco test strip contains: • Enzyme Glucose Oxidase (Aspergillus Sp.) ≥ 1IU • Other ingredients (Mediator, Surfactant, Stabilizing agents etc.) ≥ 200μg • Xpress Gluco Test Strips are used to measure glucose in Capillary whole blood outside of the body (in vitro diagnostic use). • Use Xpress Gluco Test Strips only with the Xpress Gluco Blood Glucose Test System. • Xpress Gluco Test Strips are plasma calibrated to allow easy comparison of results with laboratory methods. • This system is not intended for use in the diagnosis of diabetes mellitus. • This system is not recommended for Neonates Blood samples. Result interpretation: • Xpress Gluco Meter delivers plasma equivalent results and are displayed in mg/dL. • The measurement range of the meter is 20-800mg/dL. • Your blood glucose values will vary due to such things as diet, time of day and what you are doing. Your healthcare professional will help you to understand these variations. You should set your own range of expected blood glucose values, testing times, and discuss your blood glucose results with your healthcare professional. • When blood is added to the Xpress Gluco test strip, the chemicals within the strip react with the blood to create a tiny electrical current. • Your meter will read that current and display you the blood glucose level. • Use fresh whole blood sample only. • Sample size: 0.5uL • Analysis time: 5 seconds • System Measurement Range: 20-800 mg/dL • Hemocrit Range: 25-55 % Safety Information Important saftey handling: • Wash hands thoroughly, with soap and water before and after testing • Never use fingerstick devices for more than one person. Use auto disabling, single use fingerstick devices for assisted monitoring of blood glucose. Storage & Handling: • Store the strips in their original vial in a cool, dry place between: 0°-50° C (32° and 122° F). Keep away from direct sunlight and heat. • Do not refrigerate or freeze. • When you take a strip from the vial, close the cap immediately. Use the strip immediately. • Check the expiry date on the vial. If the expiry date has passed, do not use the strips. Important health-related information: • Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult your physician or doctor immediately. • Test results below 70 mg/dL. mean low blood glucose (hypoglycemia). • Test results greater than 180 mg/dL mean high blood glucose (hyperglycemia). • If you get results below 70 mg/dL or above 180 mg/dL and do not have symptoms of hypoglycemia or hyperglycemia, repeat the test. If you have symptoms or continue to get results that fall below 70 mg/dL or above 180 mg/dL, follow the treatment/advice of your healthcare professional. • If you are experiencing symptoms that are not consistent with your blood glucose test and you have followed all instructions described in the Xpress Gluco owner’s booklet, consult your healthcare professional Other Info UNEXPECTED RESULTS: Very high or very low blood glucose readings can indicate a serious medical condition. Repeat the test if you see an unusual reading. If these results are still unusual, or do not match your symptoms, contact your health care professional for advice. Hi or Low readings may indicate hyper or hypoglycemia and should be treated immediately. ABOUT ALTERNATIVE SITE TESTING: Test can be done on alternative site (other than fingertip). However, there are limitations. Please consult your physician before perfoming AST.

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Glycohemoglobin Analysis

XPRESSGLUCO+ strips make the testing experience superior. These Glucometer strips are for self-testing by people with diabetes at home and health care professionals in a clinical setting to monitor glucose concentrations in capillary whole blood drawn from the fingertips, forearm, upper arm, palm, calf or thigh Accurex Blood Glucose test strips provide accurate results in just 5 seconds. Buy Xpress Gluco + Test Strips (Pack of 100 Strips) Online from Accurex Point of Care (POC) Diagnostics. The Sugar machine strips require a sample volume of 0.5 μL and taking just 5 seconds to return a test result. XPRESSGLUCO+ Blood Glucose Test Strips are used with the XPRESSGLUCO+ Blood Glucose Meters. They are intended for self-testing by people with diabetes at home and health care professionals in a clinical setting to monitor glucose concentrations in capillary whole blood drawn from the fingertips, forearm, upper arm, palm, calf or thigh. They are for testing outside the body (in vitro diagnostic use only). Donot use them for diagnosis of diabetes or testing on neonates. Specification Glucose in the blood samples mixes with a special chemical in the test strip and produces a small electric current. The amount of current produced changes with the amount of glucose in the blood. The glucose meter measures the strength of the current and displays the results as a blood glucose level. Specification Glucose in the blood samples mixes with a special chemical in the test strip and produces a small electric current. The amount of current produced changes with the amount of glucose in the blood. The glucose meter measures the strength of the current and displays the results as a blood glucose level. Safety Information • Discard used test strips and lancets responsibly according to your local regulations. • Keep test strips vial away from children. A child could choke on the test strips. The test strips and their vial contain agents that may be harmful if swallowed. If they are swallowed, promptly see a doctor for immediate assistance. Do not change medication based on the test results without the advice of a physician or healthcare professional. Other Info Each test strip is plasma-calibrated†, requiring a sample volume of 0.5 μL and taking just 5 seconds to return a test result. The test range is 20 to 600 mg/dL (or 1.1 to 33.3 mmol/L) with resolution at 1 mg/dL (0.1 mmol/L). †Plasma-calibrated: Test results produced on capillary whole blood samples by XPRESSGLUCO+ System are compared with the results of the corresponding plasma samples tested by the YSI 2300 Glucose Analyzer, calibrated by YSI 2747 Glucose Standard (a NIST traceable glucose standard). The margin of error of the YSI 2300 Glucose Analyzer measurement is 0.289 mg/dL when the blood glucose concentration is higher than 100 mg/dL, or 0.029 mg/dL when the blood glucose concentration is lower than 100 mg/dL. (1 mmol/L= 18 mg/dL).

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immunoassayReagents

INTENDED USE The Finecare™ S100β Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative determination of S100β in human serum, plasma or whole blood. The test is used as an aid to the assessment of the level of cerebral injury. STORAGE AND STABILITY 1. Store the test kit at 4 ~ 30 ℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

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