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immunoassayReagents

INTENDED USE The Finecare™ LH Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Luteinizing hormone (LH) in human whole blood, serum or plasma. This test is used as an aid to diagnose the ovulation cycle, premature ovarian failure and gonadal hypoplasia. 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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Instruments

The SV300 is a state-of-the-art ventilator that's simple to configure, easy to operate, and versatile in use. It treats pediatric and adult patients with all acuity levels at ICUs and Intermediate Care. Adaptive With its comprehensive list of standard features, including the latest modes of ventilation, the SV300 is appropriate for all levels of patient acuity and in all care settings, from the patient's bedside to transport to another point of care. Comprehensive Equipped with functions that are usually found on intensive care ventilators, the SV300 comes with extensive ventilation modes and unique features that make it a top level ventilator. p84-s4-1 Volumetric CO₂ measurement p84-s4-2 Weaning indicators p84-s4-3 O₂ Therapy p84-s4-4 Intelli Cycle Thanks to the intuitive UI design of the SV300, each function is in logical order so that clinicians do not need to navigate a complex menu. In addition, both the valves and flow sensor support autoclaving. This safety concept is designed to meet the current clinical trends of protecting patients even under the most demanding conditions.

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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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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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Urinalysis Analyzer

High Performance "Full Automated System" Color Touch Panel for good usability 7 inch WVGA color touchscreen with high operability displays measurement results, instrument conditions and operating instructions. "Sample delivery system" enables micro volume samples to be measured As the sample is drawn through the nozzle and delivered correctly and quantitatively to each pad of the strip, the micro volume samples (minimum 1mL) can be measured easily. No cross contaminations are found on the reagent portions despite high sample volume. Sample Urine Test items Glu, Pro, Bil, Uro, Ket, pH, Nit, Bld, Leu, S.G., Alb, Cre(Alb/Cre ratio, Pro/Cre ratio can be calculated), turbidity and color tone Wavelength 5 LED wavelengths (430, 500, 565, 635, 760nm) Measurement principle Test strip :Dual-wavelength reflectance method (One-wavelength for Bld) Specific gravity :Reflection refractometryColor hue :Light-transmission measurementTurbidity :Light-scattering measurement method Test strip AUTION Sticks (10EA & 10PA) , Uriflet S 11UA Reaction time Approximately 60 seconds Throughput 225 samples per hour Strip storage Maximum 400 strips (200 strips x 2 feeder boxes) Required sample volume Normal, STAT measurement: Minimum 2 mL Small volume measurement: Minimum 1 mL Sample consumption Normal, STAT measurement: Maximum 0.90 mL Small volume measurement: Maximum 0.45 mL Sample container Sample tubes (length: 95 - 110 mm, diameter: ø14.0 - 15.8 mm) Maximum sample load 100 samples (Circulation) Data memory Normal, STAT, small volume measurement: 2500 tests Control measurement: 200 tests Check measurement: 50 tests Trouble list: 100 tests Display Large color liquid crystal display (800 × 480 dots) Built-in printer 58-mm width printer paper (24 digits) External output 1 port (Replaceable with the optional Ethernet terminal) Communication method RS-232C compliant (Switchable between one-way and two-way) Measurement environment Temperature: 10 - 30°C; Humidity: 30 - 60% RH (No condensation) Power requirements 100 - 240 V AC (Maximum power line fluctuation of ±10%), 50/60 Hz Power consumption 150VA (Maximum) Dimensions 530 (W) × 530 (D) × 550 (H) mm (including the sampler) Weight Main body: Approximately 36 kg Sampler: Approximately 4 kg

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Laboratory Testing Analyzer

The ADAMS A1c, HA-8180T is a fully automated Glycohemoglobin analyzer based on HPLC (High Performance Liquid Chromatography) and is highly effective for ß-thalassemia testing. Measurement speed: 3.5 minutes/test Measurement Item as below HbA2 HbF HbA1c (Stable HbA1c, S-A1c), HbS, HbC, HbE and HbD can be detected. Column design with no more pre-filter change. Color LCD with reagent level, graphs on screen. Samples Whole blood or hemolysis sample Measurement items HbA1c(Stable HbA1c, S-A1c), HbA2 and HbF (HbS, HbC, HbE and HbD can be detected.) Reagents *1 ELUENT 80A, ELUENT 80B, ELUENT 80CT and HEMOLYSIS WASHING SOLUTION 80H Column *2 COLUMN UNIT 80T Measurement principle Reversed-phase cation exchange chromatography Detection method Dual-wavelength colorimetry (wavelengths measured: 420nm/500nm) Resolution 0.1% Ratio, 1 mmol/mol Measurement range *3 HbA1c : 3-20%, 9-195 mmol/mol HbA2 : 2-10% HbF : 0-100% Guaranteed measurement range *4 HbA1c : 4.2-12.9%, 22-117 mmol/mol HbA2 : 2.4-6.3% HbF : 0.1-14.3% Processing speed 210 seconds per sample Sample consumption Approx.14μL(whole blood) Sample container Blood collection tube (12.3 to 15mm diameter) × ( 75 to 100mm length) Sample cup(500μL) Sampling method Cap-Piercing Rack type ARKRAY racks Number of measurement samples One-way transportation (factory set) : Maximum 50 samples Loop transportation : Maximum 100 samples Column temperature Approx. 39℃ Display Color graphic LCD with backlight Memory capacity 500 test results ( including calibration results ) Built-in Printer Termal printer, 58mm thermal paper External output Serial 1 port (Can be optionally used as an Ethernet port.) Measurement conditions Temperature : 15-30℃ Humidity : 20-80% relative humidity (non-condensing ) Required sample volume Blood collection tube : Minimum 10mm away from the bottom Sample cup : 400μL or more Warm-up time Maximum 30 min. Dimensions 530(W)×530(D)×530(H)mm (Not including the hemolysis washing solution bottle) Weight Analyzer: Approx. 39kg, Sampler: Approx. 4kg Power supply AC100V-240V ±10% 50/60Hz Power consumption Max. 300 VA *1, *2 Reagents and column are sold separately from HA-8180T analyzer. *3 Error-free measurement ranges. *4 Guaranteed ranges for obtaining results equivalent to those from HA-8160 TP mode measurement. ※Design and specications may be changed without prior notice

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Glucometer

Accu-Chek® Instant Blood glucose monitor Your effortless choice Item Description Wishing there was an easy way to monitor your blood glucose levels? With the new Accu-Chek Instant meter, it's as easy and fast as checking your phone messages. There is no setup required – just insert a test strip, apply a small blood sample and read your blood glucose result on the large display. Additional specifications Model: Accu‑Chek Instant wireless blood glucose meter​ Meter storage conditions: Temperature: -25 – 70° C Memory capacity: The meter automatically stores at least 720 blood glucose results in memory, but only the last blood glucose result and your 7, 30, and 90 day averages can be viewed on the meter. To view stored blood glucose results, transfer them to a compatible software application. The meter automatically stores at least 30 control results in memory, but only the current control result can be viewed on the meter. To view stored control results, transfer them to a compatible software application. Sample claims: Capillary: Yes Venous: Yes Arterial: Yes Neonate: Yes Non-fingerstick sample Claim: Palm, forearm, upper arm Measuring principle: FAD glucose dehydrogenase (GDH) Measuring time: 4 Sec Measuring conditions: 4 °C to 45 °C (39 °F to 113 °F) Hematocrit range: 10 to 65 % Humidity range: 10 to 90 % Altitude independence: 0 to 3,094 m (10,150 ft) Automatic off: 90 seconds after performing a test, 15 seconds after test strip is removed, or 5 seconds from the last test result screen. Weight: Approx. 40 g (with batteries) Construction: Hand-held Protection class: III Meter type: The Accu-Chek Instant meter is suitable for continuous operation. Interfaces: Connectivity using BLE wireless Technology to mySugr App; USB interface with USB cable to transfer data to the Accu‑Chek Connect Online system. Benefits and Features Effortless Bluetooth synchronization with mySugr diabetes management app The intuitive target range indicator gives you visual reassurance. It can be individualized to suit your personal therapy goals Only what you need: Your test result and your averages (7/30/90 days) are visible on the meter Sleek, modern design with large, easy-to-read BG numbers and a bright, backlit display No set up required – just insert a strip, apply a small blood sample, and read your blood glucose result on the large display Easy-edge test strip: Apply a small drop of blood anywhere along the wide, yellow edge Proven accuracy guaranteed by the makers of the Accu-Chek brand, fulfilling the requirements of the ISO 15197:2013, EN ISO 15197:2015 All data can be uploaded to the mySugr by using Bluetooth Low Energy wireless technology and to Accu-Chek Connect Online portal by using USB Test strips come in a 10, 25, 50 vial so you can choose whatever fits your budget or therapy Enjoy virtually pain-free testing with the Accu-Chek Softclix lancing device

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