Urine Pregnancy Test Strip FDA 510k Approval CE Certificate (CE 0197) ISO 13485 Certificate
Urine Pregnancy Test Strip
Intended Use
The Urine Pregnancy Test Strip is an immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine. The test is used to obtain a visual qualitative result. For in vitro self-testing use only.
Principle
Human chorionic gonadotropin (hCG) is a hormone, produced by the developing placenta shortly after the conception and secreted into the urine. The pregnancy test contains antibodies which specifically react with this hormone.
When the strip is immersed into a urine specimen, capillary action carries the specimen to migrate along the membrane. When hCG in the sample reaches the Test Zone region of the membrane, it will form a colored line. Absence of this colored line suggests a negative result.
To serve as a procedure control, a colored line will appear at the control zone region, if the test has been performed properly.
Test Procedure
1. Remove a Testing Device from the foil pouch by tearing at the notch and place it on a level surface.
2. Holding a Sample Dropper vertically, add exactly 2-3 drops of urine specimen to the sample marked S.
3. Read results in 5 minutes. Do not read results after more than 5 minutes.
Interpretation of result
Positive(Pregnant)
Both C line and T line appear in the viewing window accordingly, indicating you are probably pregnant. One line may be lighter than the other, they do not have to match.
Negative (Not pregnant)
Only one line, the C line, appears in the control region, indicating you are probably not pregnant.
Invalid
The result is invalid if no red line appears in the control region, even if a line appears in the test region. You should repeat the test with a new midstream test.
Material Provided
Each test contains:
1. One test strip
2. One desiccant
Each kit contains:
1. 100 test strips
2. 1 instruction
CE Certificate:
Urine Pregnancy Test Strip
