Pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic
gonadotropin (HCG) in urine for early detection of pregnancy.
Product Type | In Vitro Diagnostic Medical Device |
Methodology | Colloidal Gold Immune Chromatographic Assay |
Specimen | Urine/Serum |
Specificity | 25mIU/ml |
Product Specification | • Response time: 1~5 minutes • Accuracy: ≥ 99% • Size: 2.5mm 3.0mm 3.5mm 4.0mm 4.5mm 6.0mm • Packaging: 1/2/5/25/50/100pcs/box |
Shelf time | 24 months |
Certification | CE, ISO13485, FSC |
Place of origin | China |
Allow the specimens to reach room temperature before testing. Remove the strip from the pouch.
Immerse the strip into the urine with the arrow end pointing toward the urine and do not pass the MAX (maximum) line. Take the strip out after 15 seconds and lay it on a clean, dry, non-absorbent surface.
Wait for colored bands. Read the result within 5 mins. Then discard the strip after single use.
Positive:
Two distinct color bands appear- one on the control and one on the test region. This indicates that pregnancy has been detected. The color intensity of the test bands may vary during pregnancy.
Negative:
Only one color band appears on the control line, and no band appears on the test region. This means there is no pregnancy detected.
Invalid:
There are no visible bands at all, or if one red band apprears only on the test region. If this happens, repeat a new test. If test still fails, please contact the distributor with the lot number.
Q1:Can I have sample for testing?
A:Yes, we can provide free sample for many products. And we will return the freight on the first order.
Q2:Can I add my logo on the medical products?
A:Yes,OEM and ODM are available for us. Official authorization will be required.
Q3:How can i get the after-service?
A: We will be responsible for our products during its validity.
Q4:Do you have inspection procedures for medical products?
A:We have strict QC policy under ISO system. We will conduct 100% self-inspection before packing with QC and QA team.
Q5:Can we mix the 20ft container?
A:Yes, if the items meet our min order qty.
Q6:Will you help me register the products in my country ?
A: We have professional registration team, who can help prepare certification or CTD registration dossiers if required.
Q7:What is the delivery time ?
A: It is around 30-45 days.