510k and CE Digital Pregnancy Rapid Test Portable Easy Test
Intended use
The MissLan Digital hCG Pregnancy Test is a fast and easy-to-use
pregnancy test.
It is used for the qualitative detection of hCG in urine samples as
an aid in early detection of pregnancy.
It is intended for use by people who would like to find out whether
they are pregnant at home.
This test is intended for in vitro diagnostic use only.
Test method and result
Certificates
Company profile
Guangzhou Decheng Biotechnology Co., Ltd. located in Guangzhou,
China, is a newly grown POCT company devoted to the R&D,
manufacture and sales of rapid diagnostic reagents and related
equipment in IVD (in vitro diagnostic) field. The factory covers an
area of 10,000 square meters, ISO 9001, ISO 13485, MDSAP, BRC and
BSCI certified. Most products are CE, FDA, TGA and HSA certified.
We are able to supply reliable finished products and also very
happy to offer OEM or ODM service and integrated solution to our
customers.
FAQ
1. My result is Pregnant. What should I do?
The positive test results may indicate pregnancy. See your doctor
to confirm,who can advise you on your next steps.
2. My result is Not Pregnant. What does this mean?
When the test result is negative, it indicates that you may not be
pregnant. lfpregnancy is still suspected, test again using a new
MissLantm Digital Pregnancy Rapid Test with morning urine 48-72
hours later. lf you still get a negative resultand your period is
late, you should see your doctor.
3.How does MissLanTm Digital Pregnancy Rapid Test work?
lt detects the pregnancy hormone hCG (human Chorionic
Gonadotrophin) in urine.
4. Can any medication or conditions affect the results?
Medications containing hCG can affect the result. A number of
conditions otherthan pregnancy cause elevated levels of hCG and
could cause misleading resultsUnclean urine collection containers
or improper operation will also produceincorrect results.
5.How do I know that the test was run properly?
In normal using, an hourglass symbol will appear in the display
screen after addingsample. lf it does not display on the screen one
minute after sample adding, itindicates that the operation is
abnormal. t is necessary to retest with a new test.When an open
book symbol appears in the display screen, it indicates thatthe
test is invalid. Please make sure that vou have conducted the test
correctlyaccording to the instructions, and retest with a new test.
