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Pregnancy Test Cassette

4mm big size

comfortable result reading

A full set dropper and cartridge

3 drops of urine sample

SKU: C101C1 Category:


One Step HCG Test Cassette is an in vitro diagnostic home use test device intended for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy .

It is intended for over-the-counter (OTC) use. For in vitro diagnostic home use only.

Product NameHCG Pregnancy Test cassette
Brand NameCIBIO ® or OEM
MethodologyColloidal Gold
Kits content1. Test cassette
 2. Desiccant
 3. Instruction for use
Assay TypeQualitative Detection
Cut-off Level10, 20 or 25 mIU/ml
Cassette Size4.0mm
CertificatesCE 0123, ISO 13485, FDA 510K, MHRA, CFS/ FSC
AccuracyOver 99%
Storage Temperature4-30 degree centigrade
Shelf Life36 Months
Delivery time15-30 days
OEM ServicesLogo, pouch, box, insert, private label
Loading PortGuangzhou, Shenzhen

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 3 drops of the urine specimen to the sample well (with an arrow marked).

3.Read the result in five minutes. Positive results may sometimes appear as early as one minute but you should wait the full 5 minutes before determining a negative result.

Do not read results after more than 5 minutes.

Negative (not pregnant) :

Only one color band appears, in the Control Zone. No apparent band on the Test Zone. This indicates that no pregnancy has been detected.

Positive (pregnant) :

Distinct color bands appear in the Control and Test Zones. It indicates that you are pregnant.


No visible band at all, or there is a visible band only in the test region and not in the control region. Repeat with a new test kit.

Qus: There is much difference between the control lines of two tests. Is this a concern?

No. Variations in the color of the control band will not affect the test result.

Qus: Can test results be interpreted after more than five minutes?

No. Test results must be read in 5 minutes. A negative result may change to a false positive within minutes after the end of the testing period, which would not be an accurate reading. It is always best to read the results at the 5 minute testing period and then discard the test to avoid confusion.

Qus: How soon should I use the pregnancy test after tearing pouch?

The results of the package opened stability studies show that the products quality was stable and valid within 1.5 hours. Given variations in temperature and humidity that may occur , we suggest to use the test immediately after opening.


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