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immunoassayReagents

INTENDED USE The Finecare™ TSH Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of thyroid stimulating hormone (TSH) in human whole blood, serum or plasma. This test is used as an aid to assist in the assessment of pituitary gland and 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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immunoassayReagents

INTENDED USE The Finecare™ Progesterone Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of progesterone in human serum, plasma or whole blood. The test is used as an aid to the track ovulation. 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™ Testosterone Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative measurement of Testosterone in human whole blood, serum or plasma. The test is to be used as an aid in the diagnosis of diseases related to abnormal testosterone levels. STORAGE AND STABILITY 1. Store the test kit at 4~30ºC up to the expiration date printed on the package. 2. If removed from refrigerator, allow the test to return to room temperature for 30 minutes 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™ One Step cTnT Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay for quantitative determination of cTnT concentration in human venous whole blood, serum or plasma specimen. It is mainly used as an aid to the diagnosis of myocardial infarction. STORAGE AND STABILITY 1.Store at 4~30 °C up to the expiration date printed on the package. 2. Do not remove the Test Cartridges from the pouch until ready to use. The Test Cartridges should be used within 1 hour once opened.

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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

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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