CIBIO® Pregnancy Test Cassette
Cibio 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 Name||HCG Pregnancy Test Cassette|
|Brand Name||CIBIO® or OEM|
|Kits content||1. Test cassette|
|3. Instruction for use|
|Assay Type||Qualitative Detection|
|Cut-off Level||10, 20 or 25 mIU/ml|
|Certificates||CE 0123, ISO 13485, FDA 510K, MHRA, CFS/ FSC|
|Storage Temperature||4-30 degree centigrade|
|Shelf Life||24-36 Months|
|Delivery time||15-30 days|
|OEM Services||Logo, pouch, box, insert|
|Loading Port||Guangzhou, Shenzhen|
How To Do The Test?
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.
How To Read The Results?
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.
NOTE: if the color in the Test Zone is weak, it is recommended that the test be repeated in 48 hours, or if the test shows negative but you suspect you may still be pregnant, the test may be repeated after a few days.