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    The cassette format requires women to collect a urine sample, following which the user has to add a small quantity of the collected urine to the cassette-like test device using a plastic bulb supplied with the test. Both the strip and cassette test formats were primarily designed to be used by healthcare professionals in a clinical setting.

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    This product design comprised an inexpensive CCD camera as a colorimetric sensor, mass-produced electronic components to realize low production and maintenance costs, and commercially available urine tester strips to enable users measure urine compounds easily.

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    The Micral-Test ® is used as an aid in early diagnosis of microalbuminuria via detection of microalbumin in urine. 1,2,3 Fast and easy After 60 seconds, the result is ready for visual reading with a convenient color comparison on the strip box. The Micral-Test strip is easy to handle. 2 Special design of the Micral-Test strip delivers accurate ...

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    Urinalysis Reagent Strips (Urine) Package Insert 10 2014-8-26 · INTENDED USE The Urinalysis Reagent Strips (Urine) are firm plastic strips onto which several separate reagent areas are affixed. The test is for the detection of one or more of the following analytes in urine: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific ...

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    2021-4-21 · Bladder cancer (BC) is the 5th most common cancer in the USA. Non-muscle invasive bladder cancer represents about 70% of all cases and has generally a favorable outcome. However, recurrence rates as high as 60 to 70% and progression rates of 10 to 20% necessitate intensive surveillance with cystoscopy. The invasiveness and high cost of cystoscopy poses significant burden …

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    Purchase Multistix® Siemens Urine Dipstick. Multistix®, by Seimens, are blood and urinalysis test strips that can be used for screening urinary tract infections and disorders. They are also known as urine dipsticks. These firm plastic strips have separate reagent areas and are used to test for ten separate reagents in urine.

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  • MAR 23 2011 - Food and Drug Administration

    2011-4-25 · illuminate the test strips for measurement. It utilizes a (CMOS) image sensor that captures a color image of each of the test pads. The CMOS Design image sensor is able to photograph almost the whole length (100mm) of the urine test strip and all of its width. 6. Urine color is measured by 6. Urine color is measured

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    2019-5-30 · Home monitoring of urine protein is a critical component of disease management in childhood nephrotic syndrome. We describe the development of a novel mobile application, UrApp – Nephrotic Syndrome Manager, to aid disease monitoring. UrApp was iteratively developed by a panel of two pediatric nephrologists and three research engineers from May 2017 to October 2018 for Apple …

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    2021-4-21 · Bladder cancer (BC) is the 5th most common cancer in the USA. Non-muscle invasive bladder cancer represents about 70% of all cases and has generally a favorable outcome. However, recurrence rates as high as 60 to 70% and progression rates of 10 to 20% necessitate intensive surveillance with cystoscopy. The invasiveness and high cost of cystoscopy poses significant burden …

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    2018-6-5 · Urine tests for diabetes aren't used in diagnosis, but they can be used to help manage the condition. Learn about the 2 different types: the glucose level test and the ketone test. Find out what ...

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  • Micral-Test® strip - Roche

    The Micral-Test ® is used as an aid in early diagnosis of microalbuminuria via detection of microalbumin in urine. 1,2,3 Fast and easy After 60 seconds, the result is ready for visual reading with a convenient color comparison on the strip box. The Micral-Test strip is easy to handle. 2 Special design of the Micral-Test strip delivers accurate ...

    Get Price
  • Medical Multistix® Siemens Urine Dipstick - Henry

    Purchase Multistix® Siemens Urine Dipstick. Multistix®, by Seimens, are blood and urinalysis test strips that can be used for screening urinary tract infections and disorders. They are also known as urine dipsticks. These firm plastic strips have separate reagent areas and are used to test for ten separate reagents in urine.

    Get Price
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    •The strips can be read visually, requiring no additional equipment. • Certain configurations of strips may also be read instrumentally on the Clinitek 500, 200+, 100 or 50 urine chemistry analyzers, which offer increased standardization in urinalysis. • The break-resistant plastic vial holds 100 reagent test strips. Tests urine for ...

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    2008-6-24 · Each test was run and interpreted according to its package insert and was performed by the subject without supervision. A summary of the results is tabulated below: Currently Marketed HCG device (+) Currently Marketed HCG device (-) Total One Step HCG Urine Pregnancy Test strips (+) 65 - 65 One Step HCG Urine Pregnancy Test strips (-) - 55 55

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    2012-9-28 · BD BBL INH test strips were based on a modified assay by Kilburn et al. . Studies suggested that INH test strips based on the Kilburn et al. assay had a sensitivity range of 93% to 99.5% and a specificity range of 96.4% to 100% –. To our knowledge, there have not been any studies validating the BD BBL INH test strips.

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    2019-5-30 · Home monitoring of urine protein is a critical component of disease management in childhood nephrotic syndrome. We describe the development of a novel mobile application, UrApp – Nephrotic Syndrome Manager, to aid disease monitoring. UrApp was iteratively developed by a panel of two pediatric nephrologists and three research engineers from May 2017 to October 2018 for Apple …

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    2019-1-29 · 1 . 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION . DECISION SUMMARY . A. 510(k) Number: K182692 B. Purpose for Submission: To obtain clearance for a new device, BD MAX CTGCTV2 on BD MAX System

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    BioAssay Systems develops and markets innovative and high-throughput assay solutions to satisfy the ever increasing demands of the life sciences industry. BioAssay Systems offers assay kits that are simple and convenient to use, which are superior in performance and require little to no time for assay optimization. We focus on safe, non-radioactive formats such as absorbance, fluorescence and ...

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  • Medical Multistix® Siemens Urine Dipstick - Henry

    Purchase Multistix® Siemens Urine Dipstick. Multistix®, by Seimens, are blood and urinalysis test strips that can be used for screening urinary tract infections and disorders. They are also known as urine dipsticks. These firm plastic strips have separate reagent areas and are used to test for ten separate reagents in urine.

    Get Price
  • Multistix Siemens Urinalysis Test Strips 10 SG,

    •The strips can be read visually, requiring no additional equipment. • Certain configurations of strips may also be read instrumentally on the Clinitek 500, 200+, 100 or 50 urine chemistry analyzers, which offer increased standardization in urinalysis. • The break-resistant plastic vial holds 100 reagent test strips. Tests urine for ...

    Get Price
  • SCREEN QUICKLY. TREAT FASTER. - Medline Industries

    2018-10-4 · MPH30025SA Medline Strep A Test Strips 25/bx BioSign Rapid Flu A+B Test ... – Combo+ test detects 20 mlU/ml for urine and 10 mlU/ml for serum ... » A new standard in workflow flexibility, 24/7 testing accuracy, and user-friendly design to help improve patient outcomes

    Get Price
  • 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

    2008-6-24 · Each test was run and interpreted according to its package insert and was performed by the subject without supervision. A summary of the results is tabulated below: Currently Marketed HCG device (+) Currently Marketed HCG device (-) Total One Step HCG Urine Pregnancy Test strips (+) 65 - 65 One Step HCG Urine Pregnancy Test strips (-) - 55 55

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  • Point-of-Care Urine Tests for Smoking Status and

    2012-9-28 · BD BBL INH test strips were based on a modified assay by Kilburn et al. . Studies suggested that INH test strips based on the Kilburn et al. assay had a sensitivity range of 93% to 99.5% and a specificity range of 96.4% to 100% –. To our knowledge, there have not been any studies validating the BD BBL INH test strips.

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    diabetes type 2 urine test strips ?blood sugar. 1. Plan ahead. The best time to discuss sick-day management with your health-care team is before you become sick. You should agree on how to manage your blood glucose, when to test for ketones, and, most important, when to seek medical help. Keep adequate supplies of test strips, ketone strips ...

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    2014-3-14 · Recommendations for the Laboratory-Based Detection of Chlamydia trachomatis and Neisseria gonorrhoeae — 2014. Prepared by. John R. Papp, PhD 1. Julius Schachter, PhD 2. Charlotte A. Gaydos, DrPH 3. Barbara Van Der Pol, PhD 4. 1 Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC. 2 University of California at San Francisco, …

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    BioAssay Systems develops and markets innovative and high-throughput assay solutions to satisfy the ever increasing demands of the life sciences industry. BioAssay Systems offers assay kits that are simple and convenient to use, which are superior in performance and require little to no time for assay optimization. We focus on safe, non-radioactive formats such as absorbance, fluorescence and ...

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