One Step hCG Pregnancy Test Cassettes CLIA Waived Health Canada Approved 25/Box
Brand : Wondfo USA
- SKU:
- W1-C
- Per Each:
- 25
Wondfo One Step hCG Pregnancy Urine Test
The hCG series professional pregnancy cassette with pipette tests is the preferred clinical brand for early detection of hCG (Human Chorionic Gonadotropin) in serum or urine specimens. The One Step hCG Pregnancy Test Cassette CLIA Waived is used to obtain a visual, qualitative result for early detection of pregnancy. The pregnancy test cassette kit is for use in the monitoring of early pregnancy (6-15 days after egg fertilization) with the test line having an accurate sensitivity of 20 mIU/mL and specificity >99%.
Early pregnancy tests work by detecting the increase in human Chorionic Gonadotropin (hCG) hormone in urine that starts to develop after the fertilization of the egg (ovum). HCG rapidly starts to increase at exponential levels (see Pregnancy hCG development table).
Each home pregnancy test kit has both U.S. FDA 510k Cleared and Health Canada Medical Device Licensed and is sold internationally at manufacturer-direct, wholesale prices, providing an inexpensive pregnancy test alternative. Whether it is a clinical or home application, these pregnancy tests are useful tools for pre-screening purposes that show easy-to-read and accurate results within just minutes.
Features & Benefits
- CLIA Waived
- Easy-to-use pregnancy test. Cassette includes a dropper to collect the exact amount of the urine sample
- 99% accurate - same as lab results
- Simple, easy, and accurate
- Results in 5 minutes
- Designed for professional and home users
- FDA 510(k) Cleared
- Detect Pregnancy as early as 1 day after the first missed period
- Health Canada Class II Approved
- Built-in control system
- Room temperature storage
- Shelf-life 24 months from date of manufacture
- Add 3 drops to the well
- Ideal for low-volume donations
- Most commonly used format
- Enclosed in a moisture-proof pouch with a desiccant for long-term storage (up to 24 months).
- Cassette has a plastic molding with a patient ID window for writing test: date, name, batch, test results
Product Specifications
| Description | |
| Sample Type | Urine |
| Time to Results | 3 to 5 minutes |
| Kit Storage Conditions | 39°F to 86°F (4°C to 30°C) |
| Analytical Sensitivity | 10mIU/mL 25mIU/mL |
| Specificity | >99% |
| Shelf Life | 24 months from date of manufacture |
| CLIA Complexity | Waived |
| HC (Health Canada) | Class II |