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.

The OnSite Chikungunya IgM Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM anti-chikungunya (CHIK) virus in human serum, plasma or whole blood. Uses serum, plasma or whole blood specimen Utilizes recombinant antigen derived from the CHIK structure protein IgM immunoassay is the most practical lab method Distinguish from dengue infection which presents with similar symptoms Clinical performance: Sensitivity: 90.4% Specificity: 98.0% comparing to a commercial ELISA Cross-Reactivity: no cross-reactivity found on 10-40 specimens from the 14 disease states and special conditions, such as dengue, Zika, malaria, HIV, TB, HAV, pregnant woman and others No interference with some common substances, such as Acetominophen (20 mg/dL), Heparin (3000 U/L), Ascorbic acid (20 mg/dL), Human IgG (1000 mg/dL), Bilirubin (20 mg/dL), Glucose (55 mmol/L), Creatinine (442 μmol/L), Salicylic acid (4.34 mmol/L), EDTA (3.4 μmol/L), Sodium citrate (3.8%) Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (5 μL) Sample diluent (REF SB-R0066, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Inserts U.S. CDC Chikungunya Virus Homepage: (Transmission, Prevention, etc.) WHO: Chikungunya Virus Fact Sheets

The OnSite Leptospira IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay that can be performed within 15-20 minutes by minimally skilled personnel, and without the use of laboratory equipment. This test is intended to be used for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals, and provides a preliminary test result to aid in the diagnosis of infection with L. interrogans. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Recommended for use: Any person presenting with clinical signs or symptoms consistent with acute infection with interrogans including: high fever, headache, chills, muscle aches, vomiting, jaundice, red eyes, abdominal pain, diarrhea, skin rash After exposure to a known contaminated source Accuracy: 100% specificity and 100% sensitivity in comparison with a reference rapid test on the market Cross Reactivity: No false positive results were observed on specimens from TP, HIV, Dengue, TB, Typhoid Ab , HBsAg, HCV Ab, HEV Ab, H.P Ab, HAV, HCG, RF, ANA, HAMA Interference: No interference were seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 3.8 %; Heparin: 3,000 U/L; Creatinine: 442 μmol/L; Bilirubin: 20 mg/dL; EDTA: 3.4 μmol/L; Hemoglobin: 2g/L; Human IgG: 1000 mg/dL; AlbuminL 60 g/L Shelf life: 24 month Individually sealed foil pouches containing: One cassette device One desiccant 5 μL capillary tubes Sample diluent (REF SB-R0101, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Inserts U.S. CDC Leptospira Homepage: About Leptospira WHO: Leptospirosis Fact Sheets

Accu-Chek® Active blood glucose meter Personalised Diabetes Coaching Accurate, no coding, easy Item Description The Accu-Chek Active blood glucose meter packs many powerful features into a smaller size. No coding reduces handling steps, see test result averages up to 90 days, get alerts if your test strips are expired or if you’ve underdosed, re-dose within 10 seconds, set pre-and post-meal reminders to test, and more. Benefits and Features accurate: Accurate1 blood glucose measurement easy: No coding for even easier blood glucose monitoring easy-to-read display (new typeface) intuitive handling with just 2 buttons safe: Underdose detection visual double check 10 seconds re-dose option clever: Pre- and postmeal markers postprandial reminder 7,14,30 or now 90 day test averages USB interface for data transfer Remark: Previous Accu-Chek Active meter generations will be upgraded to no coding via black activation chip . Know more>> 1The Accu-Chek Active bGM system meets the DIN EN ISO 15197:2013 requirements (data on file, 2014). Additional specifications Meter type : Accu-Chek Active meter (Model GB) Catalogue no. / Serial no. : See type plate on the back of the meter Test principle : Determination of glucose in fresh capillary blood by reflectance photometry. Blood glucose values can be tested in whole blood or plasma. The meter displays blood glucose values corresponding to those in plasma. Measuring interval : 10-600 mg/dL Blood volume : 1-2 μl Measuring time : Test strip in the meter: approx. 5 seconds Test strip outside the meter: approx. 08 seconds Power supply : 1 battery (type CR2032) Battery life : approx. 1000 tests or approx. 1 year Automatic power-off : after 30 or 90 seconds depending on operating status Memory : 500 test results with time and date, as well as 7, 14, 30 and 90 days averages Temperature : During testing: +8 to +42°C During storage without battery: -25 to +70°C During storage with battery: -20 to +50°C Atmospheric humidity : During testing: up to 85% relative humidity During testing: up to 93% relative humidity Altitude: Sea level to 4000 m Dimensions : 97.8 x 46.8 x 19.1 mm Weight : Without battery: approx. 46 g With battery: approx. 50 g Display : 96-segment liquid crystal display (LCD) Interface : USB (Micro B) Safety class : III Electromagnetic compatibility : The Accu-Chek Active meter meets the electromagnetic immunity requirements and the electromagnetic emissions requirements as per EN 61326-2-6 and EN ISO 15197 Annex A. The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000-4-2. Performance analysis : Calibration and traceability: The performance data for the Accu-Chek Active bGM system was calibrated using venous blood containing various glucose concentrations. Reference values are obtained using the hexokinase method, which is calibrated using the ID-GCMS method. Accuracy performance : The Accu-Chek Active bGM system meets the DIN EN ISO 15197:2013 requirements (data on file, 2014). How to use Accu-Chek Active blood glucose meter Testing your blood glucose is an essential part of managing diabetes. The Accu-Chek Active blood glucose meter can help to make it convenient by giving you fast, hassle-free, and accurate results in 4 simple steps. Insert the glucose test strip Prick your finger with the lancet to draw out a blood drop. Carefully touch the blood drop onto the green field of the test strip. Read the blood glucose result.

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

BC-6800 Today, laboratories not only need more reliable routine CBC plus 5-part diff WBC testing by way of high processing speed, but are also looking for options that extend the analyzer's output in form of Reticulocytes, Nucleated RBCs, Fluorescent Platelet counts etc. for wider clinical application and research. On the other hand, they are restricted by limited budgets. BC-6800 can help to meet all these needs just perfectly and even exceed the expectations. Additional parameters for further clinical applications IMG(#,%) parameters provide information about immature granulocyte, including promyelocytes, myelocytes and metamyelocytes. HFC*(#,%) parameters represent high fluorescent cell population, such as blasts and atypical lymphocytes. RET(#,%) extend valuable help in the differential diagnosis and/or therapeutic monitoring of anemias. IRF is parameter concerning immature reticulocytes, which can assist in early diagnosis of anemia and monitoring the bone marrow response to therapy. InR*(#,‰) are parameters regarding infected red blood cell. The red blood cells may infected by plasmodium, which can cause malaria. * means research parameters SF Cube Technology SF Cube is a pathbreaking technology for reliable blood cell analysis, including WBC differential, Reticulocytes and NRBC with efficient flagging. After reaction with proprietory reagents, the targeted blood cells undergo 3D analysis using information from scatter of laser light at two angles and fluorescence signals. The 3D scattergram builds the power to better identify and differentiate blood cell populations, especially to reveal abnormal cell population undetected by other techniques. Minimizing interference to ensure more accurate results NRBCs are counted in a dedicated channel by SF cube method, which automatically corrects total WBC count and 5-part Diff results when NRBCs are detected. The Focusing Flow-DC method minimizes the interference traditionally encountered in DC technology to produce near gaussian histograms. PLT-O result avoids the interference from microcytic and fragmented RBCs, large platelets and/or platelet clumps by fluorescent stain, and enhances the results accuracy and sensitivity. High automation to minimize the workload Throughput for 125 tests/hour, autoloader for 100 sample tubes capacity Bi-directional LIS with HL7 or ASTM communication protocol Customizable re-exam rules allow users to define their re-exam criterion according to lab’s practice

The SAL 6000 modular system delivers fast throughput and powerful integration across immunoassay and chemistry systems. Broad assays can be tested with one sample tube, which can maximize operation efficiency and increase lab productivity. Product Description SAL 6000 Modular System delivers fast throughput and seamless integration of CL-2000i Chemiluminescence Immunoassay System and BS-800 Modular System. In conjunction with the SPL 1000 Sample Processing System, this scalable platform not only provides optimized workflow, it also offers satisfactory operator experience. Features · Seamless integration, workflow optimization · Uniform software interface, easy of operation · One tube sampling, flexible to test · Technology and quality heritage · Flexible scalability, on-site upgrading · Comprehensive test menu Product Specification Automation Fully Automatic Brand Mindray Model Name/Number SAL 6000 Assays Clinical Chemistry Power Supply 220 V Usage/Application Hospital Frequency 50 Hz

ntented Use STANDARD F H. pylori Ag FIA is a fluorescent immunoassay for the detection of H.pylori antigen in human fecal specimens. Specification Specimen Feces Test time 10 minutes Specimen volume 40 - 70mg Sensitivity 100% (5/5) Specificity 100% (150/150) Storage temperature 2-30℃ / 36-86℉

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