FDA Taiwan single pack 100 pcs blood ketone strips

Product Description
TD-4631(Ket) Use With XPER Technology(TD-4206) /Single pack Box NO METER
USE Model:TD-4631 Ketone strip (TD-4206)
Single Pack: 100 strips each box
Strip Appearance
1. Absorbent Hole
Apply a drop of blood here.
The blood will automatically be absorbed.
2. Confirmation Window
This is where you confirm if enough blood has been
drawn into the absorbent hole of the strip. 3. Test Strip Handle
Hold this part to insert the test strip into the slot.
4. Contact Bars
Insert this end of the test strip into the meter.
Push it in firmly until it will go no further.
ATTENTION
The front side of the test strip should face up when inserting the test strip.Test results might be wrong if the contact bar is not fully inserted into the test slot.
Testing Your β-Ketone
PLEASE WASH AND DRY YOUR HANDS BEFORE PERFORMING ANY TESTING.
STEP 1
Insert the test strip fully into the slot of your meter until it will go no further. When the strip is fully inserted, the meter will do several self-checks.
STEP 2
Collect a blood sample with the test strip. A sufficient quantity of blood is required for the test to provide accurate results. Touch the blood drop with the absorbent hole of the test strip, and wait until the confirmation window is fully covered. The meter will start counting down. Do NOT apply a smeared blood sample.
STEP 3
After few seconds, the meter will display your β-Ketone level. The last reading will be automatically saved in the meter.Turn it off by removing the test strip and throw away the used test strip. The used lancet and test strip are potentially biohazardous. Please dispose of them carefully according to your local regulations. Please refer to your Owner’s Manual for further information.
Please refer to your Owner's Manual for more information.
Accuracy
The reference method is B-Hydroxybutyrate LiquiColor®. The reagent can quantifiably detect the presence of β-Ketone in patients with suspected diabetic ketoacidosis. β-Ketone
n = 333Regression
Capillary samplesRange, meany = 1.0677x - 0.0024
R² = 0.9957
Range: 0.10 to 7.77 mmol/L
Mean: 0.79 mmol/L β-Ketone
n = 333Regression
Venous samplesRange, meany = 0.9492x - 0.0105
R² = 0.9771
Range: 0.04 to 7.58 mmol/L
Mean: 1.51 mmol/L
Precision β-Ketone
Concentration (mmol/L)
0.5 mmol/L2.9 mmol/L0.5 mmol/LMean
0.520
2.9435.003SD0.0660.0970.130CV%---3.302.60
Chemical Components β-Hydroxybutyrate Dehydrogenase (Pseudomonas sp.)≥0.5 UMediator55%NAD0.5 μgEnzyme protector8%Non-reactive ingredients29%
Packaging & Shipping
P a c k a g i n g Single pack 100 strips each boxCarton (Large Quantity)
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