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'other similar models'

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Hematology

n large laboratories, rows of instruments are seen working tirelessly like miniature factories – only they produce not commodities but medical test results. Mindray CAL 8000 new-generation cellular automation line is one of them, but unlike a typical workhorse, it is intelligent. It is a highly automated workstation for smarter, faster, and more accurate cellular analysis. It can perform competently in the face of these challenges. The workstation can hold up to four units of BC-6800 automated hematology analyzer, which utilizes the advanced SF Cube technology and 3-D scatter grams to help doctors better differentiate blood cell populations and reveal abnormal cells undetectable by conventional techniques. With 125 CBC tests per hour per unit, BC-6800 brings the process rate of the workstation to 20–30 percent higher than other similar models, effectively alleviating laboratory's stress during the peak processing hours. On CAL 8000, the hematology analyzer, slide maker and stainer, CRP analyzer, and HbA1c analyzer are all integrated into one seamless production line through automated track modules and trolley. Simply by loading a single tube of blood sample onto the automation system, one can get all the test results. This innovative walk-away automation functionality has made possible the CBC+CRP+HbA1c testing all in one streamlined workstation for the first time in the industry. It offers a smart solution, or rather, a smart expert – the labX pert 2.0. It is a software that can automatically sort out the suspected samples for manual validation. The pathologist then decides if rerun or microscopic review is warranted based on their clinical experience. It avoids wasting slides and reduces extra work. Moreover, the onboard automated re-exam functionality also helps enhance work efficiency. The CMU software The touch screen is the “brain” of CAL 8000. It optimizes the distribution of workload between each analyzer unit and decides which sample requires a blood smear. It displays the status of each analyzer or SC-120 installed on CAL 8000 as well as the volume of balance reagent. This intuitive software can tell the users all necessary information of CAL 8000 at any given time. Consequently, the users spend less time operating CAL 8000 and can arrange their working schedule better. Multi “R” tests The CAL 8000 can automatically distribute the samples with “Repeat”, “Rerun” and “Reflex” criteria which are pre-defined by users.The re-exam criteria on CAL 8000 can be defined by many conditions, such as time, patient’s age, gender, department, etc. This helps minimize the number of blood smears. Special tube racks The special tube racks utilize different barcodes to differentiate specific testing purposes, such as “QC”, “Slide making & staining only” and “RET test only”. The special tube racks can carry the tubes to perform these specific functions in the simplest way.

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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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Glucometer

Accu-Chek® Guide Blood Glucose Meter Surprisingly Clever Diabetes is complex. Your testing doesn’t have to be Item Description Diabetes is complex. Your testing doesn't have to be with the Accu-Chek® Guide blood glucose monitoring system. With a spill resistant SmartPack® vial, a strip that lets you place a small drop of blood anywhere along the end, and an app that automatically logs results to your phone, it's a surprisingly simple way to manage your diabetes. Benefits and Features Simple to log results without a paper logbook - automatically logs results right to a mySugr app on your smartphone Simple to take just one strip - spill-resistant SmartPack vial lets you take one and spill none Simple to dispose off used test strips - push-button strip ejector means you don't have to touch used strips Simple to see, day or night - strip port light for testing in daytime, nighttime or anytime Simple to be more accurate - delivers advanced 10/10 accuracy for reliable results you can trust1,2,3 Meter Specifications Models: Accu‑Chek Guide wireless blood glucose meter Serial number: Unique serial number etched into meter back Sample claims: Capillary: Yes Venous: ROW = Yes Arterial: ROW = Yes Non-fingerstick sample claim ROW: Palm, forearm, upper arm Measuring principle: FAD glucose dehydrogenase (GDH) Measuring time: Less than 4 seconds Measuring conditions: 4°C to 45 °C (39°F to 113 °F) Storage conditions: -25 °C to +70 °C (-13 °F to +158 °F) Hematocrit range: 10 to 65% Humidity range: 10 to 90 % Altitude independence: 0 to 3,094 m (10,150 ft) Memory capacity: Up to 720 measurements with date and time; 32 control measurements Test averages: 7, 14, 30 and 90 days Data transfer wireless connectivity: using Bluetooth Smart Low Energy Dimensions: 80 x 47 x 20 mm (L x W x H) Weight Approximately: 40 g with batteries Display: Large backlit LCD display with full-text capabilities Beep tone: Yes (factory setting ON) Batteries: (2) 3-volt lithium coin cell type CR2032 Auto power off: 15 seconds after removing a test strip; 90 seconds otherwise Blood volume: 0.6 μL Measuring range: 10 to 600 mg/dL Sample types: Capillary, venous, arterial and neonate Sample dosing: Capillary fill function; suitable for AST Test strip stability 18 months after production date: Test strips are stable (even after opening) until the expiry date printed on the test strip vial. Note: Test strip container must be tightly closed after each strip is removed. Storage temperature : 4 °C to 30 °C (39 °F to 86 °F)

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HEMOGLOBIN METER

Mispa HbX Portable Haemoglobin Analyzer Overview Mispa HbX , Smart Haemoglobin analyzer is a symbol of advanced point of care equipment with modern technology and convenience, designed to deliver high accuracy, quality results with least turnaround time and low maintenance. Best in Class Hemoglobin Meter Mispa HbX, the Smart Haemoglobin Analyzer, is the best example of an advanced point-of-care hemoglobin reader with modern technology. It is easy to use and designed to deliver accurate, high-quality results with the shortest turnaround time and minimal maintenance. This digital Hb meter is one of the best hemoglobin meters available. Working of A Hemoglobin Meter or a hemoglobin reader A hemoglobin meter or a hemoglobin reader measures the amounts of hemoglobin and hematocrit in whole blood. Hemoglobin tests are typically performed to determine the RBC count, the severity of anemia, hematocrit, and other haematological factors. It is widely utilized during blood donations and key decisions such as blood transfusions. HbX works with Spectrophotometry Scattered compensation Technology for accurate and quick results Results will be retrieved with in less than 3 seconds after sample reading starts Sample Required: 7ul Capillary or Venous blood Three Step procedure makes HbX more convenient to use CV value will be less than 1.5 % 6 Hours Battery Backup makes it a hand equipment 2000 Data storage capacity Micro Fluidic cuvettes with 2 year Shelf life

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immunoassayReagents

INTENDED USE The Finecare™ Vitamin D Rapid Quantitative Test along with Finecare™ FIA Meter is a fluorescence immunoassay quantitative determination of total 25(OH) D2/D3 level in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency. STORAGE AND STABILITY 1. Store at 4°C~30°C up to the expiration date. 2. The solid marker bottle can be stored at 2°C~8°C for 28 days after being reconstituted. 3. Do not remove the device from the pouch until ready to use. The Test Cartridges should be used within 1 hour once opened.

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Immunoassay Reagents

INTENDED USE The Finecare™ 2019-nCoV lgM/lgG Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of IgG and IgM antibodies of novel coronaviruses (2019-nCoV) in human whole blood, serum and plasma specimen. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV. The test provides preliminary test results. Negative results cannot exclude the possibility of 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision. STORAGE AND STABILITY 1. Store at 4-30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

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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 The 4th Generation HIV TRI-DOT + Ag test is a visual, rapid, sensitive and accurate immunoassay for the differential detection of HIV-1 p24 antigen and HIV-1 & HIV-2 antibodies (IgM,IgG & IgA) in Human Serum or Plasma. The test is a screening test for p24 antigen (HIV-1), anti-HIV-1 & anti-HIV-2 and is for in vitro diagnostic use only. It is intended for screening of blood donors or other individuals at risk for HIV-1 & HIV-2 infection and for clinical diagnostic testing. Salient Features Rapid visual test ,based on enzyme immuno assay & Flow Through Technology. Rapid test for simultaneous and differential detection of p24 Antigen & antibodies for HIV on the same device. Ideal for Blood screening: detects sero-negative HIV Cases. Use of gp-41, C terminus of gp120 for HIV-1 antibodies & gp-36 for HIV -2 antibodies. Detection of Group ‘0’ & subtype ‘C’ of HIV-1, which is most prevalent in India. Unique washing steps for clear Interpretation of Results. Evaluated by National Institute of Biologicals- 100 % Sensitivity & 100 % Specificity. Long Shelf life: 15 months at 2-8° C.

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