Total IgE Immunoglobulin E test ( Immunofluorescence )
Intended Use
The Total-IgE quantitative test ( Immunofluorescence Assay ) is a fluorescence immunoassay (FIA) for the quantitative determination of total IgE in human whole blood/serum/ plasma. It is useful as an aid in diagnosis and management of allergic disease. For in vitro diagnostic use only.
For the auxiliary diagnosis of allergic diseases, eczematous or non-eczema dermatitis, asthma, etc. This product is not recommended for physical examination of healthy people, and positive or negative test results only represent positive or negative
results for the corresponding IgE antibodies, and the correlation with whether the patient has the disease is uncertain, and should not be used as the only indicator for the evaluation of the patient's condition.
MATERIALS
Materials Provided
Test devices Droppers Buffer Package insert
Materials Required But Not Provided
Specimen collection containers Lancets (for fingerstick whole blood only)
Centrifuge Micropipette Timer
DIRECTIONS FOR USE
1.This test is for in vitro diagnostic use only. Do not swallow.
2.Discard after first use.The test cannot be reused.
3.Do not use test kit beyond expiration date.
4.Do not use the kit if the pouch is punctured or not well sealed.
5.Keep out of the reach of children.
6.Keep your hand dry and clean before and during testing.
7.Do not use the product out of doors.
8.The procedures should be followed precisely for accurate results.
9.Do not disassemble the battery. The battery is not detachable or changeable.
10.Please follow local regulations to discard used tests.
11.This device meets the electromagnetic emissions requirement of EN61326.Its electromagnetic emission is therefor low.Interference from other electrically driven equipment is not expected. This test should not be used in close proximity to sources of strong electromagnetic radiation,e.g.mobile phone,as there may prevent the test from working correctly.To avoid electrostatic discharge,do not use the test in a very dry environment,especially one in which synthetic materials are present.
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