'plasma immunoassay reagents'

INTENDED USE The Finecare™ cTn I/NT-proBNP Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of cardiac Troponin I (cTn I) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of myocardial infarction and suspected congestive heart failure. 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.

Using best-in-class technology, the Mindray CL-6000i is a chemiluminescence immunoassay analyzer with high throughput, high performance and high reliability. Features Throughput: up to 480 tests per hour Measurement principle: enhanced ALP-AMPPD method Reagent carousel: 36 reagent positions with non-stop refrigerating Sample handling: up to 300 samples can be loaded in one batch, sample loading and offloading continuously by sample racks, fast prioritizing STAT samples Sample volume: 5-110 μL Continuously loading of reagents, substrate, cuvettes, wash buffer and waste bags Zero daily maintenance Product Specification Model Name/Number CL-6000i Usage/Application Hospital Brand Mindray Sample Volume Range 5-110 microlitre Throughput up to 480 tests per hour Measurement Principle enhanced ALP-AMPPD method Reagent Carousel 36 reagent positions with non-stop refrigerating Sample Handling up to 300 samples can be loaded in one batch,sample loading and offloading continuously by sample r

Fully Automated Chemiluminescence Immunoassay Analyzer Introducing iFlash 1200, a chemiluminescence immunoassay analyzer that offers fully automated immunoassay analysis using Magnetic particle-based Direct Chemiluminescence technology. With a high throughput of up to 120 tests per hour and a first result available in just 13 minutes, iFlash 1200 is one of the fastest and most efficient immunoassay analyzers available on the market. The instrument features continuous STAT sample loading capacity with 16 sample positions, continuous reagents loading capacity with 15 reagent positions, and continuous loading of reaction vessels with a capacity of 500 cuvettes. Additionally, iFlash 1200 uses Acridinium Ester Labeled Direct Chemiluminescence for highly accurate and reliable results, and comes with ready-to-use reagents in convenient 2 x 50 tests pack size for simplified testing. Overall, iFlash 1200 is an innovative and versatile immunoassay analyzer that is perfect for laboratories that require high throughput and rapid turnaround times. iFlash 1200 chemiluminescence immunoassay analyzer Key Features: 1.Continuous loading of reagents with convenient pack size of 2 x 50 tests 2.Continous loading of 500 reaction cuvettes for longer walkaway time 3. 4 step magnetic separation for achieving high precision and quality results 4.Non contact vortex mixer-Highly Efficient technology to prevent carryover & cross contamination Additional information General Information Throughput : upto 120 tests/hour Time to First Results :13 minutes Detection Principle Magnetic particle Based Direct Chemiluminescence Chemiluminescence Label :Acridinium Ester Sample System Sample Position :16 sample position Types of Sample tube :Microcup & blood collecting tubes Sample Volume :5~150μL Reagent System Reagent Position :15 reagent positions with onboard refrigeration Reagent Carousel Temp :2-8 °C Reagent Detection :Reagent Level Tracking Reagent Pack : 2 x 50 tests Reagent Carousel Incubation Capacity :48 reaction vessels Incubation Temperature :37°C+-0.3°C Mixing System :Non-Contact Vortex Mixer Operating Conditions Power Supply :100~240V, 50/60HZ Power Consumption :600VA Temperature :10~30°C Weight :120 Kg Reagents iFlash 1200 reagents iFlash 1200 reagents Pack size 2 x 50 Tests 28 days On board reagent stability 28 days Calibration stability Built in Calibrators for all Parameters

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)

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.

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.

INTENDED USE The Finecare™ Ferritin Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative determination of Ferritin in human whole blood, serum or plasma. The test is used as an aid to the assessment of iron deficiency anemia. STORAGE AND STABILITY 1. Store the test kit at 4 ~30℃ up to the expiration date printed on the package. 2. Do not remove the Test Cartridge from the pouch until ready to use. The Test Cartridge should be used within 1 hour once opened.

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.

Dengue NS1 Antigen Test The Finecare™ Dengue NS1 Ag Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of Dengue NS1 antigen in whole blood, serum or plasma specimen. It is useful as an aid in screening of early Dengue virus infection.