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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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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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Clinical Chemistry

Product Specification Model Name/Number HumaStar 200 Brand Human Automation Fully Automatic Display Digital Dimensions 69 x 76 x 52 cm (WxDxH) Frequency 50/60 Hz Voltage 220-240 or 110-120 Vac Temperature 16-30 Degree C Throughput Up to 200 t/h throughput Weight 51 kg Reaction volume 210-350 il Wash station 6 dispensing needles Water consumption < 2 l/h (8 ml/test) Languages English, French, Spanish Software (other languages can be added) Humidity < 80 % non-condensing Data External computer required (Pentium IV, 2 GHz Mode Open, random-access, STAT Product Description Product Detail : Unique Random-Access Analyzers for Small to Medium Size Laboratories Unique design Unique software architecture Unique features Analysis Endpoint (bichromatic), Differential endpoint (with sample blank), Fixed time, Kinetic (bichromatic) Multi-standard (up to 8), factor, linear, non linear (cubic-spline, poly-linear and logit-log four parameters) Samples Removable sample tray 60 positions: primary tubes 12–12.5x100 mm and 10 mm cups Optional: sample tray for 20 primary tubes 12–16x100 mm and 20 cups 3.5 ml Sample volume: 2–300 µl Internal barcode reader Automatic pre- and post-dilution Test profiles and replicates Reagents Removable reagent tray 30 reagent / diluent positions 50 and 20 ml bottles, adapter for tubes and cups Reagent volumes: 5–350 µl Refrigeration to ~9 Degree C below ambient (at bottom of bottle) Substrates, Enzymatic, Turbidimetric Reaction Reaction volume: 210–350 µl 80 reusable Bionex® cuvettes 6 mm optical path Heat transfer by air Pipetting Needle shock detector Capacitive liquid level detector Wash station 8-step cuvette wash station Systemic and special washing solution HumaStar 200: 6 dispensing needles Water consumption < 2 l/h (8 ml/test) Optical system 9 discrete wavelengths (340, 405, 505, 546, 578, 600, 650, 700 nm, one free position) Band pass: +/– 5 nm Photometric linearity: 0–2.5 Abs Stability: <1 % drift per day Management 20 GB HDD, 512 MB RAM, CD/R, USB) Windows 7® with .NET framework 4.0 English, French, Spanish OS recommended Core i3TM or dedicated graphic card recommended Minimum 900 dots resolution Designed for touch screen (1280x1024 pixel) LIS: Bi-directional, polling mode, ASTM, ethernet Printouts By patient, single test, complete sample, work sheet, method and QCs, calibration curves, kinetics, continuous printing

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Diabetes

Product Features: Better precision, CV < 2.5 % Patented CLE technology enables complete elimination of labile glycohemoglobin ensuring accurate HbA1c results. HbA1c test results in 3.5 minutes with HbA2/HbF flagging. Separation of hemoglobin fractions Complete removal of labile fraction up to 10% No interference of HbF up to 10% No interference of lipemia or icterus, can run on non-fasting patient samples HbA1c reportability presence of HbS, HbC, HbD and HbE Compact bench top model User friendly touch screen operation Sampling from multiple sized primary tubes, including microcapillary collection tubes On board QC functions with Levey-Jennings and statistical calculations Unlimited storage of calibration, QC data and chromatograms No sample preparation required Simple reagent and column replacement Automated maintenance RFID reagent identification and tracking Automatic barcode identification of samples NGSP certified Calibrators and Controls IFCC traceable Complete kit with buffers, calibrator and column Product Application: Hba1c Testing Sampler Handler: 10 Position Rack Loader, positive identification by internal barcode reader Sample Type: Whole blood on EDTA K3 or K2 anticoagulant Haemolysate from EDTA whole blood samples Time for Analysis: Throughput approximately 3.5 minutes between samples Interferences: Complete removal (not separation) of labile up to 10% Sampling System: Sample Aspiration Probe coupled with a high precision, Sample Aspiration Volume: 14.5 µl in whole blood, 670 µl in lysate mode. Pump: 2 high pressure syringe pumps Detector Type: UV-Vis Reagent Traceability: RFID Printer: Built- in thermal printer with possibility to connect to external printer

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Clinical Chemistry

EM 360 is a Fully Automated Clinical Chemistry Analyser which is time tested and proven technology. It is designed to provide the most demanding productivity, speed and operational ease. EM 360 with a throughput of 360 tests/hour offers flexibility in operation and rugged performance to win against high workload, tight deadlines, multiple tasks and complexity of testing. It yields high quality results for virtually any biochemistry test to deliver quick, efficient and consistent performance. Product Features: Automated, Discrete, Patient prioritized, Floor model Based on proven technology, Diffraction Grating Separate probes for Reagent R1 & R2 and dedicated probe for sample Low reading volume of 200 µl only Onboard cooling for reagents to enhance the reagent stability Barcode for reagents & samples (Optional) Wide test menu Product Applications: End Point Reactions: Glucose, Cholesterol, Triglycerides, Albumin, Total Protein, Uric Acid, Calcium, Magnesium, Bilirubin Total, Bilirubin Direct Kinetic Reactions: SGOT, SGPT, GGT, LDH, CK, CK MB, ALP, ACP, Amylase, Lipase Two Point Rate Reactions: Urea, Creatinine Immunoturbidimetric Chemistries: RA, CRP, ASO, Direct HDL, Direct LDL, Apo A, ApoB, Lp (a) Special Chemistries: HbA1c, Iron, Ferritin, Phosphorus, Microprotein, Ammonia, Bicarbonates System Type: Discrete, automated, random access, patient prioritized clinical chemistry analyzer Throughput: 360 tests / hour photometric and 600 tests / hour with ISE* (*optional ISE with Na+, K+, Cl-, Li+) Analytical Methods: 1-Point, 2-Point, Rate-A, Rate-B, Direct Potentiometry (optional) Barcode Reader: For reagents and samples (optional) Reaction Tray: 60 hard glass cuvettes Reaction Mixing: Stirrer with variable speed Minimum reaction Volume: 150 μl with maximum 200 μl reading volume On-board Laundry: 5 stage cleaning, 2 stage drying Photometer: Multi-wavelength diffraction grating with 12 wavelengths (340, 376, 415, 450, 480, 505, 546, 570, 600, 660, 700, 750 nm) OD Range: 0.0 - 3.0 Light Source: Halogen lamp Detector: Silicon photo-diode Water Consumption: < 10 litres Programmable Parameters: Default system pack parameters + upto 99 user defined parameters, Unlimited profile and unlimited calculation items Quality Control: QC plot data with QC rules. Provision for lab mean. Twin plot Calibration: K-Factor, Linear (1, 2 point & multipoint), 4P and 5P Logit-log, cubic spline, exponential, polynomial, On-board serial dilution for calibrator Power Requirement: AC 220 V ± 10 %, 50 Hz or AC 110 V ± 10 %, 60 Hz Power Consumption: 800 VA Dimension (mm): Approx. 675 (W) x 840 (D) x 1120 (H) Weight: Approx. 150 kgs. SAMPLE HANDLING Sample: Serum, Plasma, Urine, CSF, Whole blood, other Sample Unit: 82 positions for samples, blank , controls, calibrators, STAT sample Sample Pipetting: 2 - 70 µl (adjustable in 0.1 µl step) for Biochemistry, 70 µl fixed for ISE Capacitance probe with liquid level sensing & vertical obstruction detection, serum indices Auto Rerun: Repeat with same, increased or decreased volume ( upto 1:150) Sample Tubes /Cups: Primary tubes of 5 ml, 7 ml, 10 ml and sample cups REAGENT HANDLING Reagent Tray: 50 positions for reagents with onboard cooling Reagent Pipetting: R1: 50 - 300 µl (adjustable in 1 µl step) R2: 10 - 200 µl (adjustable in 1 µl step) Capacitance probe with level sensing & vertical obstruction detection SYSTEM INTERFACE: Analyzer-PC: USB PC - Host Computer: Bidirectional TCP / IP & RS - 232 PC - Printer: USB Operating System: Windows Based Database: Unlimited Results

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Clinical Chemistry

Product Description: XL-640 with CRS is a random access, discrete, patient prioritized, fully automated clinical chemistry analyzer with autoloader designed to meet the needs of today’s modern clinical laboratories with high workload. Once samples are loaded, it is a complete walk-away system. XL 640 CRS is designed to operate smoothly over the long haul and to deliver consistent quality report. Product Features: Throughput of 400 tests/ hour (Photometric) and 640 tests/hour with ISE 56 Reagent Positions with On-board cooling for reagents 162 Sample positions with /Autoloader Separate probes for reagent R1 & R2 and dedicated probe for sample Clot detection for sample probe, Reflex testing and Serum Indices identification 72 permanent hard glass cuvettes with On-board Laundry Automatic dilution for high abnormal samples & Auto Rerun facility Extensive QC Programmes with Levy –Jennings Curve & QC rules. Automatic calculation for Mean SD & CV% Direct loading for primary tubes Touch screen User Friendly GUI with Bi-directional connectivity. System General System Type: Automated, Discrete, Random Access, Patient Prioritized Clinical Chemistry Analyzer with Autoloader Throughput: 400 photometric tests/hour & 640 tests/hour with ISE (*optional ISE with Na, K, Cl, Li) Analytical Methods: 1-Point, 2-Point, Rate-A, Rate-B, Direct Potentiometry(optional) Barcode Reader: Both for Samples & Reagents (Optional) Reactions Tray: 72 hard glass cuvettes Reaction Mixing: Dual Stirrer with variable speed Reading Volume: 180 µl On-Board Laundry: 6 stage cleaning, 2 stage drying Photometer: Multi-wavelength diffraction grating with 12 wavelengths (340, 376, 415, 450, 480, 505, 546, 570, 600, 660, 700 & 750 nm) O.D. Range: 0 - 3.0 Light Source: Halogen Lamp Detector: Silicon Photodiodes Water Consumption: < 14 liters/hour Programmable Parameters: Default system pack parameters + upto 99 user defined parameters, Unlimited profiles and unlimited calculation items Quality Control: Q.C. plot data with Q.C. Rules. Provision for lab mean. Twin plot. Caliberation: K- factor, Linear (1,2 point and multipoint) 4P and 5P Logit-log, Cubic spline,exponential, polynomial. On-board serial dilution for calibrator Power Requirement: AC 220 V ± 10 %, 50 Hz or AC 110 V ± 10 %, 60 Hz Power Consumption: 800 VA Dimensions: Approximately 897 mm (w) x 655 mm (D) x 1170 mm (H) Weight: Approximately 200 Kg Sample Handling Sample: Serum, Plasma, Urine, CSF, Whole blood, other Sample Unit: upto 162 positions for samples/STAT/calibrator/controls with Autoloader Sample Pipetting: 2-70 µl (adjustable in 0.1 µl steps) for biochemistry,70 µl fixed for ISE capacitance probe with liquid level sensing and vertical obstruction detection , clot detection and serum indices and Reflex Testing Auto Rerun: Repeat with same, increade and decresaed volume (upto 1:150) Sample Tubes/Cups: Primary tubes of 5 ml, 7ml and 10 ml and sample cups Reagent Handling Reagent Tray: 56 positions for reagents with on-board cooling Reagent Pipetting: R1: 60 - 300 µl (Adjustable in 1 µl step) R2: 0 or 10 - 300 l (Adjustable in 1 µl step) Capacitance probe with level sensing and vertical obstruction detection System Interface Analyzer-PC: USB PC- HOST Computer: Bidirectional TCP/IP and RS - 232 PC- Printer: USB Operating System: Windows based with Touch Screen User Friendly GUI Database: Unlimited Results

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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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immunoassayReagents

INTENDED USE The Finecare™ AFP Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Alpha-Fetoprotein in human whole blood, serum or plasma. The test is used as an aid for early auxiliary diagnosis and the evaluation of therapeutic efficiency for primary hepatic carcinoma. 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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