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Critical Care

Product Description: Medica Corporation’s EasyLyte® analyzer is a completely automated, microprocessor-controlled electrolyte system that uses ISE (Ion Selective Electrode) technology to make electrolyte measurements. The EasyLyte measures combinations of Na+, K+, in whole blood, serum, plasma, or urine. EasyLyte incorporates state-of-the-art electronics and an innovative ergonomic design that differentiates it significantly from competitors. The analyzer also stores quality-control data that is easily accessible. Patient histories are immediately retrievable for evaluation. EasyLyte analyzers combine simple yes/no prompted operation, low maintenance, and high reliability into one economical design. Product Features: EasyLyte is Easy to Use, Easy to Operate, Easy to Maintain The entire menu is driven by 2 simple buttons Results are displayed on LCD screen as well as printouts EasyLyte does 2 point as well as 1 point calibration Facility to analyze different type of samples: whole blood, serum, plasma ,urine samples EasyLyte has capillary and syringe sampling facility EasyLyte has auto probe wiping facility Analysis of electrolytes is done using 100ul of blood and 400ul of diluted urine Rate of analysis 55 secs per sample Analyzer is capable of storing 128 patients data with trilevel QC results Analyzer has modular plug in reagent pack system EasyLyte has facility for auto calibrations with a programmed interval of 4 hrs and also calibration on demand Analyzer has facility to upgrade to a walk away Electrolyte station by use of Auto Sampler It has a built in thermal printer and a RS 232 port for interfacing Product Applications: Sodium - Na, Potassium - K CLIA Classification: Moderate Complexity Sample Type: Whole Blood, Serum, Plasma or Urine Sample Size: 100 µL Whole Blood, Serum, Plasma, 60 µL capillary or 400 µL diluted (1:10) Urine Method: Direct measurement by Ion Selective Electrode (ISE) Measurement Range: Blood Urine Na+: 20 – 200 mmol/L Na+: 25 – 1000 mmol/L K+: 0.2 – 40 mmol/L K+: 1.0 – 500 mmol/L Cl-: 25 – 200 mmol/L Cl-: 25 – 500 mmol/L Li+: 0.2 – 5.0 mmol/L Ca++: 0.1 – 6.0 mmol/L pH: 6.0 - 8.0 Units Display Resolution: Na+: 0.1 mmol/L K+: 0.01 mmol/L Cl- : 0.1 mmol/L Li+: 0.01 mmol/L Ca++: 0.01 mmol/L pH: 0.005 units Test Time: Na/K Na/K/Cl Na/K/Li Na/K/Cl/Ca Analysis time (blood) 55 sec 55 sec 55 sec 60 sec Urine mode Yes Yes Yes No Analysis time (urine) 90 sec 90 sec 90 sec N/A EasySampler Yes Yes Yes No Capillary Samples Yes Yes Yes No Data Storage: Patient Results: up to 128 samples QC Results: up to 20 each Normal, Low, and High Calibration: Automatic or On-Demand Output: 128 x 64 pixel graphic display 24 column thermal printer Serial port (RS-232), EasySampler port Ambient Conditions: 15–32oC (60–90oF), <85% humidity Power: 100-240 VAC 50/60 Hz, 0.8A Size & Weight: 9.5”W x 16.5”H x 8.0”D (24 cm W x 42 cm H x 20 cm D) 13 lbs. (5.8 kg) Reagents used with this 'EasyLyte' CLIA Classification: Moderate Complexity Sample Type: Whole Blood, Serum, Plasma or Urine Sample Size: 100 µL Whole Blood, Serum, Plasma, 60 µL capillary or 400 µL diluted (1:10) Urine Method: Direct measurement by Ion Selective Electrode (ISE) Measurement Range: Blood Urine Na+: 20 – 200 mmol/L Na+: 25 – 1000 mmol/L K+: 0.2 – 40 mmol/L K+: 1.0 – 500 mmol/L Cl-: 25 – 200 mmol/L Cl-: 25 – 500 mmol/L Li+: 0.2 – 5.0 mmol/L Ca++: 0.1 – 6.0 mmol/L pH: 6.0 - 8.0 Units Display Resolution: Na+: 0.1 mmol/L K+: 0.01 mmol/L Cl- : 0.1 mmol/L Li+: 0.01 mmol/L Ca++: 0.01 mmol/L pH: 0.005 units Test Time: Na/K Na/K/Cl Na/K/Li Na/K/Cl/Ca Analysis time (blood) 55 sec 55 sec 55 sec 60 sec Urine mode Yes Yes Yes No Analysis time (urine) 90 sec 90 sec 90 sec N/A EasySampler Yes Yes Yes No Capillary Samples Yes Yes Yes No Data Storage: Patient Results: up to 128 samples QC Results: up to 20 each Normal, Low, and High Calibration: Automatic or On-Demand Output: 128 x 64 pixel graphic display 24 column thermal printer Serial port (RS-232), EasySampler port Ambient Conditions: 15–32oC (60–90oF), <85% humidity Power: 100-240 VAC 50/60 Hz, 0.8A Size & Weight: 9.5”W x 16.5”H x 8.0”D (24 cm W x 42 cm H x 20 cm D) 13 lbs. (5.8 kg)

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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™ 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™ Prolactin Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative measurement of Prolactin (PRL) in human whole blood, serum or plasma. The test is used as an aid to the evaluation of pituitary endocrine function. 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 cassette from the pouch until ready to use. The test cassette should be used within 1 hour once opened.

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immunoassayReagents

INTENDED USE The Finecare™ Estradiol (E2) Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters is for quantitative measurement of Estradiol (E2) in human whole blood, serum or plasma. The test is used as an aid to the evaluation of ovarian diseases. 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 cassette from the pouch until ready to use. The Test cassette should be used within 1 hour once opened.

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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 HIV TRI-DOT test is a visual, rapid, sensitive and accurate immunoassay for the differential detection of HIV-1 & HIV-2 antibodies (IgG,IgM & IgA) in human serum or plasma using HIV-1 & HIV-2 Antigens immobilized on an immunofiltration membrane. The test is a screening test for Anti HIV-1 and HIV-2 and is for in vitro diagnostic use only. Salient Features Rapid visual test ,based on Flow Through Technology. Differential detection of HIV-1 & HIV-2. Detection of group ‘O’ & subtype ‘C’. Use of envelop antigens gp41& C terminus of gp120 for HIV-1 & gp36 for HIV-2. 100% sensitivity & 100% specificity as per WHO Evaluation. Shelf life 24 months at 2-8°C Available in convenient pack sizes- 50 Tests and 100 Tests. Results within 3 minutes. No instrument required. In built quality control dot.

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Rapid Test

Intended Use Advantage PAN Malaria Card is a rapid, visual and sensitive immunoassay for the qualitative diagnosis of all four Plasmodium Species (P.falciparum/P.vivax/P.malariae/P.ovale) based on pLDH antigen in human whole blood only. Salient Features Detects infection with Plasmodium species(P.falciparum/P.vivax/P.malariae/P.ovale) Excellent Sensitivity & Specificity as per WHO Malaria RDTs Evaluation. See through Device for easy result interpretation. Longer shelf life -30 months, storage at 4-30° C. Results within 20 minutes.

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