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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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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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immunoassayReagents

Cortisol Rapid Quantitative Test The Finecare™ Cortisol Rapid Quantitative Test is a fluorescence immunoassay for quantitative determination of Cortisol in human serum, plasma or whole blood. The test is used as an aid to the screening of adrenal dysfunction and assessment of the treatment effect. 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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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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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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immunoassayReagents

INTENDED USE The Finecare™ PSA Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative detemination of Prostate Specific Antigen (PSA) in human whole blood, serum or plasma. The test is used as an aid in diagnosis of prostatic cancer. STORAGE AND STABILITY 1. Store the test kit at 4~30℃ up to the expiration date 2. If removed from refrigerator, allow the test for 30 minutes to return to room temperature before testing. 3. Do not remove the device from the pouch until ready to use. The test cartridge should be used within 1 hour once opened.

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immunoassayReagents

INTENDED USE The Finecare™ FPSA Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Free Prostate Specific Antigen (FPSA) in human whole blood, serum or plasma. The test is used as an aid in diagnosis of prostatic cancer. 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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immunoassayReagents

INTENDED USE The Finecare™ CEA Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of carcino-embryonic antigen in human whole blood, serum or plasma. The test is used as an aid in the evaluation of therapeutic efficiency, prognosis and recurrence monitoring for 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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immunoassayReagents

INTENDED USE The Finecare™ T3 Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Triiodothyronine (total T3) in human serum, plasma or whole blood. The test is used as an aid to the assessment of thyroid function. 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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