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Rapid Test

STANDARD F HbA1c FIA performs quantitative analysis on glycosylated hemoglobin in whole blood samples using fluorescence immunochromatography. As STANDARD F Analyzer has been enhanced in its performance by using fluorescent substance, accurate quantitative test results can be obtained using with this product. ntented Use This product performs quantitative analysis on glycated hemoglobin in the whole blood samples. Advantage Able to perform accurate quantitative analysis using fluorescent substance Hb S, Hb F, Carbamylated Hemolgobin without interference phenomenon Automatic strip recognition by reading the information stored in 2D barcode IFCC / NGSP certified Specification Specimen Whole blood Test time 5 minutes Specimen volume 5 µl CV% <3%

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Clinical Chemistry

ADVIA 2400 Chemistry System The right balance of speed and efficiency The ADVIA® 2400 Clinical Chemistry System manages the most demanding workloads and meets high turnaround-time (TAT) goals. Its menu includes methods for testing drugs-of-abuse, therapeutic drugs (TDM) and new assays such as cystatin C and CardioPhase® hsCRP. The ADVIA 2400 Clinical Chemistry System offers: High throughput of up to 2400 tests/hour (1800 photometric and 600 ISE) to manage heavy workloads Rapid, consistent, 2-second cycle time for faster tube speed and test throughput User-defined automatic repeat, dilution, and reflex testing Large onboard reagent capacity and optional concentrated reagents help to minimize intervention demands Refrigerated onboard storage of controls and reagents for extended stability and increased productivity Automation-ready design: no additional hardware required Features & Benefits The ADVIA 2400 Clinical Chemistry System meets today’s high turnaround-time goals with a throughput of up to 2400 tests/hour. In addition to assays for general and specialty chemistries, its menu includes assays for specific protein measurement, drugs-of-abuse testing (DAT), and therapeutic drug monitoring (TDM). Interesting new assays such as cystatin C, HbA1c with automated sample pretreatment, and CardioPhase® hsCRP can now be included in your routine testing. The ADVIA 2400 Chemistry System pushes productivity levels while maintaining the reliability and stability that keep laboratories up and running. A rapid, 2-second probe cycle time maximizes tube speed and test throughput and combines with the system’s efficient automation-readiness to provide the turnaround time needed for high-volume laboratories Superior Speed and Productivity Throughput of up to 2400 tests/hour (1800 photometric and 600 ISE) to manage the heaviest workloads Rapid, consistent, 2-second cycle time Throughput of 200 tubes per hour, even when running three ISE tests and nine photometric tests per sample Automatic Sample Retain technology, auto-repeat, auto-dilution, and auto-reflex testing Automation-ready Point-in-space aspiration enables connectivity to a track. Redundant sample loading provides built-in backup and easy handling of non-routine samples. Direct sampling from track prevents tubes being detained at an analyzer and reduces aliquoting. Minimal Need for Operator Intervention Minimal-maintenance ISEs Large onboard reagent capacity and optional concentrated reagents for fewer interruptions No-maintenance, 37°C incubation oil bath Auto-calibration and auto-QC from refrigerated onboard calibrators and controls Microvolume technology with 32,000 tests onboard and up to 60 days' onboard stability for improved walkaway time. Concentrated reagents for increased maximum capacity. Remote diagnostics and Inter-Laboratory Quality Control (ILQC) options Exceptional Reliability Sample integrity check for icterus, hemolysis, and lipemia Sample probe with automatic clot/clog detection, liquid-level sensing, short-sample detection, and crash protection Advances in onboard reagent stability, calibration frequency, reduction in interferences, and expanded assay linearity

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Clinical Chemistry

The ADVIA® 1800 Clinical Chemistry System pushes the limit of productivity. Its extensive menu allows integration of testing for clinical chemistry, drugs-of-abuse, therapeutic drug monitoring (TDM) and specific proteins such as cystatin C and CardioPhase® hsCRP. The ADVIA 1800 Clinical Chemistry System offers: Throughput of up to 1,800 tests per hour to keep pace with workload peaks 200 basic metabolic panels per hour to meet turnaround-time demands Large onboard reagent capacity and optional concentrated reagents to reduce interruptions Optimal standardization of reagents and systems for efficient consumable usage Refrigerated onboard storage of controls and reagents for extended stability and increased productivity Automation-ready design: no additional hardware required Features & Benefits The ADVIA 1800® Clinical Chemistry System pushes the limit of productivity in the core lab and meets the turnaround-time (TAT) goals of today’s laboratories. Its extensive menu allows integration of general clinical chemistry testing with testing for drugs-of-abuse, TDM, special chemistry, and specific proteins such as cystatin C and CardioPhase® hsCRP. Automation-ready design Point-in-space aspiration enables connectivity to a track, VersaCell® System. Redundant sample loading provides built-in backup and easy handling of non-routine samples. Direct sampling from track prevents tubes being detained at an analyzer and reduces aliquoting. Peak productivity Throughput of up to 1,800 tests per hour provides the speed to keep pace with workload peaks. Throughput of 200 basic metabolic panels per hour helps to meet turnaround-time demands. Automatic Sample Retain technology lets you perform reruns and dilutions without the need to retrieve primary tubes. Consolidate chemistry testing on one system with a comprehensive menu, consistent cycle times, speed, and open application capability. Total system reliability Minimal-maintenance ISEs Robust hardware and simplified software design, with automatic calibration validation and tracking Advances in reagent onboard stability, calibration frequency, interference reduction and assay linearity expansion Direct water connection Remote diagnostics and Inter-Laboratory Quality Control (ILQC) options Easy efficiency Large onboard reagent capacity and optional concentrated reagents reduce interruptions. High-resolution touchscreen delivers push-button operation. Reagent pause capability and onboard Sample Pause button make loading easy. Minimal maintenance requirements, including no-maintenance oil bath, reduce hands-on time. Sample integrity checking, include serum indices reporting, short-sample flagging, and clot detection, reducing the need for manual intervention.

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Hematology

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

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Medical Equipment

In compliance with out-of-hospital patient transport standards such as EN1789, EN13718-1, IEC60601-1-12 and U.S. military standards, N1 is a highly competent solution for various out-of-hospital transport settings both on land and in air. The N1's exceptional reliability and strong performance enhance your confidence to provide seamless patient care during transport no matter intra or out of hospital. One monitor, Multiple solutions Mirror Mode Two-way screen or remote control functionality and viewing on both the 19" external display and the N1 unit - simultaneously. benevision-n1-fig2-2-pc BeneVision N1 as a Transport Monitor Enhanced data analysis greatly improves parameters' accuracy and anti-interference ability. Its fully integrated sidestream CO2 module monitors the patient's breathing situation by connecting with sampling line directly, freeing caregivers from the shackles of expanding external modules for transport. One monitor, Multiple solutions Mirror Mode Two-way screen or remote control functionality and viewing on both the 19" external display and the N1 unit - simultaneously. benevision-n1-fig2-2-pc BeneVision N1 as a Transport Monitor Enhanced data analysis greatly improves parameters' accuracy and anti-interference ability. Its fully integrated sidestream CO2 module monitors the patient's breathing situation by connecting with sampling line directly, freeing caregivers from the shackles of expanding external modules for transport. benevision-n1-fig2-1-pc BeneVision N1 as a Multi-Parameter Module Slide directly into the module slot or SMR of the N-Series monitor providing an expansive set of parameter measurements. When combined with our additional advanced parameter modules, this solution fits even the highest level of critical care environments. benevision-n1-fig2-3-pc Companion Mode Connect with N-Series host monitor via cable connection to N1 dock and have the ability for dual-screen monitoring and bi-directional control of the bedside monitor - expanding slot space for more advanced parameters and enhanced ICU workflow. Patient-Centric Data Collection When connected to a bedside patient monitor, advanced parameters collected from the host monitor such as AG and BIS, etc., will also be stored in N1 with trend data and alarm events reviewable even when it is disconnected.

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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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Rapid Test

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

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Rapid Test

The OnSite hCG Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, hCG in human serum, plasma and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite hCG Combo Rapid Test is not intended for quantitative results, nor for over the counter (OTC) sales. It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via assay of hCG, a placental hormone that may be present in human serum, plasma or urine. The hCG detection limit the OnSite hCG Combo Rapid Test is 12.5 mIU/mL in serum or plasma specimen, and 25 mIU/mL in urine specimen. It is designed for professional use only, and provides only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result. Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is 100% sensitivity and 100% specificity in urine specimens 100% sensitivity and 99.5% specificity in serum specimens Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens Analytical specificity: no cross reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH) Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert) Shelf life: 24 month Kit box package: 1. Individually sealed foil pouches containing; a. One dip strip device b. One desiccant 2. One package insert (instruction for use) Tube package: 1. Strip Package 2. One desiccant 3. One package insert (instruction for use) CTK Products at a Glance Drugs.com: Overview of Human Chorionic Gonadotropin Inserts

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Rapid Test

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

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