ISO 13485 Digital Pregnancy Test Kit For Urine HCG Detection

510K OTC Digital Pregnancy Test for Urine HCG Detection

Bright spots

Test method

Certificate

Company profile

As a high-tech manufacturer of IVD products, DoChek was founded in 2018, honored as an innovative, high-tech, specialized enterprise.

We own professional R&D, manufacture, quality management, design and sales teams. Our products cover fertility, tumor, drug of abuse tests and etc., most of which are CE, FDA, TGA and HSA approved. We’ve established a complete QMS system by passing ISO9001, ISO13485, MDSAP, BRC and BSCI.

RFQ

Q: How dose MissLan Digital PregnancyRapid Test Work?

lt tests the pregnancy hormone hCG (HUMAN chorionicgonadotropin) found in pregnant women. Test sensitivity is25mUI/ml.

Q: How does this product differ from the common one?

The digital display of this product can give us a direct and clear result as “+ or “-", or “pregnant” or “Not pregnant”.

Q: How early can we test?

The HCG test usually starts 2 days before your expected period, and can be performed 4 to 5 days before your expected period at the earliest.

Q: How do we know the test is done properly?

In normal using, an hourglass symbol will appear on the display screen after adding sample. lf it does not show on the screen 1 minute after sample adding, the operation can be deemed as abnormal. It's necessary to retest with a new midstream.When the book symbol appears on the screen, the test is wrong or invalid. Please make sure the test is done in a proper way and retest with a new midstream.

Q: The test result is positive, what should I do further?

A positive test result may indicate pregnancy. Please see your doctor for further confirmation.

Q: Does the test be affected by medication or other conditions?

• General medications such as cold medicines, antibiotics medication or other conditions?painkillers, etc.) do not affect the accuracy of the test results, but injecting or taking fertility drugs will do.
• Hematuresis, bilirubin and turbid urine do not effect the result, but higher chyle level may do.
• Unfresh or unclean test sample, unclean urine collection containers,or improper operation will produce incorrect results.
• A false negative result may occur if the HCG level is too high, due to the limitation of the methodology itself.

Q: The test result is positive,what should we do further?

A positive test result may indicate pregnancy. Please see your doctor for further confirmation.

Q: The test result is negative, what should I do further?

A negative result may indicate you are not pregnant. But if pregnancy is still suspected, retest with morning urine 48-72hours later on a new midstream. lf the test result is negative again and your period is late, please see your doctor for further check.