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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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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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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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Clinical Chemistry

Autozyme Albumin 100 Diagnostic Reagent (Pack Size : 2 x 50 ml) from Accurex. Albumin reagent is used for determination of albumin in serum or plasma based on BCG method, can be determined in 1 minute at room temperature. BCG reagent and standard should be stored at temperature indicated on the bottle label. Accurex has gained considerable expertise in manufacturing & marketing of In-vitro Diagnostic reagents. Serum albumin in the presence of Bromocresol-green under acidic condition forms a green colored complex. Albumin normal range is 3.4 to 5.4 g/dL (34 to 54 g/L). About Autozyme Albumin is a reagent set for determination of albumin in serum or plasma based on BCG method Autozyme Albumin is a single reagent system, ready to use. Autozyme Albumin is linear up to 6 gm% Albumin can be determined in 1 minute at room temperature The shelf-life of Autozyme Albumin is 18 months Pack Size : 2 x 50 ml Principle Serum albumin in the presence of Bromocresol-green under acidic condition forms a green coloured complex, The absorbance of this complex is proportional to the albumin concentration in serum or plasma. Quality Control To ensure adequate quality control, it is recommended that each batch should include a normal and an abnormal commercial reference control serum,. it should be realized that the uSe of quality control material checks both instrument and reagent functions together. Factors which might affect the performance of this test include proper instrument function, cleanliness of glassware and accuracy of pipetting. Other Details The reagents are for in vitro diagnostic use. BCG reagent and standard should be stored at temperature indicated on the bottle label.

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Clinical Chemistry

XL 1000 with the throughput of upto 1040 tests per hour is the ideal instrument for centralizing the complete biochemistry testing load on a single fully automated platform. Increased walk away productivity and less human intervention make it an ideal analyzer for large laboratories. Equipped with all necessary advanced features that one expects from a high end fully automated chemistry analyzer; sample loading through rack system, cooled calibrator and control carousel, low reading volume of 150 µL, diffraction grating with 15 wavelengths from 340 nm to 800 nm and user-friendly software, to optimize and reliably run the daily lab workload. XL 1000 is a "dream come true" workhorse for laboratories with increased workload and the perfect solution. Fully Automatic, Discrete, Patient prioritized, Random Access Clinical Chemistry Analyzer with throughput of 1040 tests/hour 3 Reagent capabilities 147 long life Hard Glass cuvettes Separate Carousel for STAT samples Onboard refrigeration for reagents Extensive database for storing patient data and Q.C. results Primary tube sampling with bar code identification 9 stage laundry for cuvettes wash 150 samples can be loaded at a time through rack system System Discrete, open, automated, random access, patient prioritized, 1/2/3 reagent system DISPENSING OF SAMPLES AND REAGENTS Sample volume: 2-60 µl (0.1 µl step), 70 µl with ISE Reagent volume: 120 µl – 550 µl 3 dispensing probes ( R1, R2/R3) equipped with liquid -level sensor and crash detector Auto-dilution of samples and calibrators Clot detection Samples Serum, urine, plasma, CSF and other Economy Minimum reaction volume: 180 µl Reusable reaction cuvettes Mixing System 2 independent stirrers 3 user selectable mixing speeds Quality Control 4 levels of control material can be used Levey-Jennigs graphs Twin Plot diagrams for monitoring of systematic and random error Reaction unit with wash station 147 reusable hard glass cuvettes Possibility of replacement of individual cuvette Wash station – cuvette rinsing and drying in nine-step procedure Automatic cuvette blank measurement before analysis Sample Autoloader 23 racks 115 sample positions on automatic autoloader Primary tubes 5, 7 and 10 ml, vacuum system tubes Barcode reader for sample identification 2 Reagent trays With 43 cooled position each Barcode reader for reagent identification 20 ml, 50 ml reagent containers, 5 ml tube with adaptor Option to use one reagent for several test simultaneously Stat Tray 45 positions Can be used for blank, controls, STAT samples Software Convenient user interface Connection to LIS Programmable auto-start from sleep mode including automatic daily maintenance Statistical methods of processing results Data export in selected format Measurement Monitoring Colour indication of sample analysis Possibility of monitoring the reaction in real time Reagent volume monitoring Informative reports on ongoing analyzer status

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Biochemistry Analyzer

Overview A fully automated POC Auto Dry Biochemistry Analyzer called Mispa Chem Dx, With Just 3 to 4 drops (100ul) of whole blood to test up to 19 General and Special chemistry tests in less than 12 minutes. Mispa Chem Dx works on absorption spectroscopy where a change in absorbance is detected by an absorption spectrum and an algorithm is used to calculate the end concentration of the sample in the reagent dry disc. The reagent disc consists of lyophilized reagent beads, diluent, and calibration details in the QR code. The reagent disc contains an intelligent internal quality control system IQC which continuously monitors the disc function to ensure reaction stability and optimal disc performance, IQC is the engine that drives the Mispa Chem Dx accurately and precisely Low Sample Consumption Easy to Use Maintenance Free Accurate Result Disposable reagent disc Sample volume: 100µl Testing time: 12 minutes / sample Temperature: 37°C ± 0.3°C Resolution: 0.001Abs Absorbance: 0-3.0Abs Sample type: Heparinized whole blood, serum, plasma (heparin) QC&Calibration: IQC (Intelligent Quality Control/Calibration) Work condition: Temperature:10-30°C Humidity: 30%-70% Testing method: End point, kinetic, fixed time, turbidmetry etc Light source: 12V/20W, Halogen tungsten lamp with life span over 2500 hours Power supply: AC 100V-240V, 50-60Hz Display: Android 7.0 inch 800*480, multi-point capacitive touch screen Storage: 500,000 results Printer: Built-in thermal printer Interface: 4 USB ports, 1 LAN port Dimension: 315*375*475mm. 4.2kg(N.W.), 7kg(G.W.)

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Intended Use The 4th Generation HCV TRI-DOT is a rapid, visual, sensitive and qualitative in vitro diagnostic test for the detection of (IgM,IgG & IgA) antibodies to Hepatitis C virus in human serum or plasma. It has been developed and designed with increased sensitivity for core and NS3 antibodies using a unique combination of modified HCV antigen. Salient Features Based on “Flow Through Technology”, which is similar to Elisa technology because of involvement of washing steps at various levels to enhance the specificity. Use of highly purified HCV antigens for Core, NS3, NS4, NS5 immobilized on the device. Detection of all the subtypes of HCV. Results within 3 minutes. In built quality control dot which validates the test. 100% Sensitivity & 98.9% Specificity as per WHO evaluation. Shelf life : 24 months at 2-8°C

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Rapid Test

Intended Use Dengue NS1 Antigen FP is a rapid solid phase immuno- chromatographic test for the qualitative detection of Dengue NS1 Antigen in human Whole Blood/ Serum/ Plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of dengue infection. Salient Features Rapid ,visual test for the qualitative detection of Dengue NS1 Antigen in whole blood/serum/Plasma. Sample can be taken from Finger prick and sample required is 4µl. Based on Sandwich principle. Detection of Dengue in Seronegative stage i.e From Day 1 of fever. Detection of all 4 serotypes of dengue virus. Reliable diagnosis of both primary and secondary infection. 100% Sensitivity & 99.96 % Specificity. Shelf life: 24 month at 2-30 °C Convenient pack Size: 10 Test. Evaluated By Referral Medical college / Hospitals /Research institutes / Labs.

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