Testi Po Uzi Diagnostike

Ghost explorer. Microdot Test Strips, 50 Strips/Bottle Use with Microdot Xtra Meters Only Chemical Composition Each Microdot® strip contains the enzyme glucose dehydrogenase (Bacillus Sp.) = 1 IU and other ingredients (mediator, NAD, lysing agents etc.) = 200 µg. Test Strips When blood is added to the Microdot® strip, the chemicals within the strip react to create a tiny electrical current. Your meter reads the current and displays your level of blood glucose. Performance Characteristics • The performance of Microdot® Test Strips has been evaluated both in laboratory and in clinical tests. • Range: measurement range of the microdot® System is 1.2 to 29.2 mg/dL. • Accuracy: The accuracy of the Microdot® System was assessed by comparing blood glucose results obtained by 102 patients at one clinical centre with those obtained using a YSI 2300 laboratory Instrument. • Clark error grid analysis: 98% A region; 2% B region Correlation coefficient R = 0.977.

• Range tested 45 to 472 mg/dL (2.5 to 26.2 mmol/L). • Slope 0.973 y-Intercept 3.96 mg/dL (0.22 mmol/L). • This means that the microdot® system compared well to a laboratory method. Precision: Within-Run Precision (20 replicates in 1 day) Glucose Value mmol/L CV% Bloodav 2.4 5.61 Bloodav 4.5 4.07 Bloodav 6.9 3.27 Bloodav 10.9 3.55 Bloodav 16.4 3.31 Total Precsion Control 2.5 5.42 Solution 6.5 4.96 20.6 4.89 This means that the strip to strip variation was not greater than 5.6%. Intended Use Microdot® Test Strips are used to measure glucose (sugar) in capillary whole blood outside of the body (in vitro diagnostic use). Use Microdot® Test Strips only with the Microdot® Blood Glucose Test System.

Microdot® Test Strips are plasma calibrated to allow easy comparison of results with laboratory methods. Storage and Handling • Store the strips in their original vial in a cool, dry place between 50° and 86° F (10°-30° C). Keep away from sunlight and heat • Do not refrigerate or freeze. • When you take a strip from the vial, close the cap immediately. Use the strip immediately. • Do not use Microdot® Test Strips more than 6 months after the vial is first opened. Write the discard date on the vial when you first open it.

• Check the expiry date on the vial. If the expiry date has passed do not use the strips.

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• Always code the meter for each new vial of strips according to the user manual. This product is classified as a Medical Device which is regulated by the FDA. This product may have regulations or restrictions in some states. It is the customer’s responsibility to determine and comply with all applicable federal, state or local laws.