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Wondfo - Model HCG-001 - Pregnancy Cassette Urine Test Kit
The Pregnancy hCG Cassette Urine Test, offered by Wondfo, is a rapid diagnostic tool designed for the early detection of pregnancy. This test is highly sensitive and reliable, with FDA approval and CLIA waiver, ensuring accuracy and safety for users. It utilizes a combination of monoclonal and polyclonal antibodies to precisely identify elevated levels of human chorionic gonadotropin (hCG) in urine samples. hCG is a glycoprotein hormone produced shortly after fertilization, making it a key marker for pregnancy detection. The test can identify hCG in urine as early as 7 to 10 days after conception, with levels peaking between 100,000-200,000 mIU/mL by 10-12 weeks of gestation. Results are interpreted visually, with color bands indicating pregnancy status. The test shows no cross-reactivity with structurally similar hormones, ensuring specificity. Designed for ease of use, individuals need only provide a urine sample, and results are quickly obtained, allowing for timely pregnancy confirmation.
Have donor provide urine sample and let stand until it’s room temperature. Open the foil pouch and remove the test device & eye dropper.
- Using the enclosed dropper, withdraw the urine sample and add 4 drops into the sample oval shaped well on the cassette.
- Results are available in within 10 minutes. Results obtained after more than 10 minutes may not be valid.
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum as early as 7 to 10 days after conception (1-4). hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period (2-4), and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. The appearance of hCG in both urine and serum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, the hCG One Step Pregnancy Test Strip (Urine) shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
- The test is CLIA Waived indicating the test is certified accurate and designed to eliminate mistakes during home use.
FDA Approved and Doctors recommended Pregnancy Test. The most sensitive rapid pregnancy test for the early pregnancy detection.
Product Description:
- Detects elevated levels of Human Chorionic Gonadotropin (hCG)
- hCG hormone level in the human body doubles approximately every 2.2 days during the first trimester
- Simple, accurate & inexpensive urine test
- FDA Cleared & CLIA Waived
- Easy to read and understand results, with 99% accuracy
- Type : Cassette
- Panel : 1
- Brand : Wondfo
- Adulterants : None
- 510 K # : K122907/K112101
- Drug Parameters : HCG
- FDA/CLIA : FDA & CLIA Waived