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Rapid Test

The OnSite HSV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. Unique test that utilizes glycoprotein G2 to differentiate between HSV-1. and HSV-2 that allows for an early start of treatment action. Immediate determination of either acute or chronic infection by detecting and differentiating IgG and IgM anti-HSV-2. High confidence as test is in agreement with market leading European ELISA: 95.3% IgG; 100% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0213, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

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Rapid Test

The OnSite HIV 1/2 Ab Plus Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of HIV-1 and HIV-2 antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood. 3rd Generation, double-antigen based test to increase the sensitivity in early detection Requires only 20 µL of specimen Use serum, plasma or whole blood Results available within 15 minutes to allow prompt action to be taken at the point of care Performance validated with BBI low titre panel and Chinese FDA HIV Ab panel Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (20 uL) Sample diluent (REF SB-R0011, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance Flyer Inserts TB-HIV Rapid Test Presentation U.S. CDC HIV Homepage: About HIV WHO: Health Topic for HIV U.S. CDC HIV Testing 101

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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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Glucometer

SD Check Gold 2 is a blood glucose self-monitoring device improved convenience from Gold model as it does not need a code chip for calibration. Advantage Fast and accurate results in 5 seconds No coding Wide pure gold electrode Specification Enzyme Glucose Oxidase biosensor Measurement Range 10 - 600mg/dL (0.6 - 33.3 mmol/L) Test Time 5 sec Sample Volume 0.9µl Hematocrit 20 - 60% Unit mg/dL Memory Up to 400 tests Battery 3V battery (CR2032) Interpretation of results Cat. No. Product Component Note 01GC22 SD CHECK® GOLD 2 Blood Glucose Monitoring System Meter, Test Strip (10EA) / Lancet(10EA) / Lancing Device / Check Strip 01GS20 SD CHECK® GOLD 2 Blood Glucose Test Strip SD CHECK® GOLD 2 Test Strip (25EA x 2 bottle)

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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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immunoassayReagents

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.

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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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immunoassayReagents

INTENDED USE The Finecare™ β2-MG Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of β2-MG (Beta-2-Microglobulin) concentration in human plasma, serum or whole blood. The test is used as an aid for the diagnosis of renal disease. 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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