Digital Early Pregnancy Test (Self-test)

FDA 510K

K251013 / K241978

Intended Use
Experience peace of mind with the Digital Early Pregnancy Test, designed for women who prioritize accuracy and clarity. This professional-grade in-vitro diagnostic (IVD) tool offers ultra-early detection by identifying hCG levels as low as 10 mIU/mL. Unlike traditional line tests that can be difficult to interpret, our intuitive digital display provides a clear “Pregnant” or “Not Pregnant” result in just 3 minutes. Engineered for convenience and hygiene, it is the ideal solution for reliable at-home self-testing.

Key Product Features
  • Ultra-Early Detection & High Sensitivity
    Equipped with a precise cut-off value of 10 mIU/mL, this test allows for initial detection earlier than standard tests, capturing the pregnancy hormone (hCG) at its earliest stages.
  • Unmistakable Digital Results
    Eliminate the guesswork of “faint lines.” The integrated LCD screen provides a clear, easy-to-read text result, ensuring total confidence in your interpretation.
  • Clinical Grade Accuracy
    Boasting over 99% accuracy from the day of your expected period, the Shinetell Plus delivers laboratory-standard reliability in the comfort of your home.
  • Rapid 3-Minute Results
    Time is of the essence when waiting for life-changing news. Our advanced rapid-test technology delivers a definitive result in just 180 seconds.
  • Ergonomic & Hygienic Design
    The midstream format features a comfortable collection grip and an absorbent tip designed for easy use, minimizing mess and maximizing hygiene during the testing process.
 
SKU: FHC-EU103H / FHC-AEU103H Categories: , ,

Price range: $2.99 through $279.99

Description
Specifications & Pack Sizes

Description

Cat. No. Reading Time Specimen Sensitivity Package Size   Certificate
Digital Pregnancy Rapid Self-Test

FHC-EU103H

3 Minutes

Urine

25 mIU/ml

1 Test

 FDA 510K / OTC cleared
K241978

FHC-AEU103H 10 mIU/ml 1 Test

FDA 510K / OTC cleared
K251053

 

Before You Begin
  • Read all instructions carefully before performing the test
  • Use the test at room temperature (15-30°C / 59-86°F)
  • For best results, test with first morning urine which contains the highest concentration of hCG
Step-by-Step Instructions

1. Prepare the Test
Remove the digital pregnancy test from the sealed foil pouch and use it as soon as possible. Do not use if the pouch is damaged or already opened.

2. Remove the Protective Cap
Carefully remove the cap from the absorbent tip to expose the sample collection area. The absorbent tip should be visible and ready for urine application.

3. Apply Urine Sample
Hold the test by the ergonomic grip area with the absorbent tip pointing downward. Place the absorbent tip directly in your urine stream for at least 5-7 seconds until thoroughly saturated.

IMPORTANT: Keep the digital display screen facing upward and avoid getting urine on the display window or electronic components.

4. Replace the Cap and Position the Test
After sample collection, immediately replace the protective cap over the absorbent tip. Lay the test flat on a clean, dry, non-absorbent surface with the display screen facing upward.

5. Wait for Digital Result
The test will begin processing immediately. You may see the display screen activate. Wait for the digital result to appear on the screen. Results will be displayed within 3 minutes.

6. Read Your Result
The digital display will clearly show one of the following results:

  • “Pregnant” – hCG detected
  • “Not Pregnant” – hCG not detected

IMPORTANT: Read results within 3-5 minutes of testing. Do not interpret results after 10 minutes as the test may become invalid.

INSTRUCTION FOR USE

Instruction for Use

Questions
  1. Could a negative result be wrong?
    It’s possible to get a negative result from a home pregnancy test when you are pregnant. This is known as a false-negative. You might get a false-negative if you:
    (a).  Take the test too early. The earlier you take a home pregnancy test, the harder it is for the test to find HCG. For the most accurate results, take a home pregnancy test after the first day of a missed period.
    (b).  Check test results too soon. Set a timer to go off at the time the test directions say you should check the result. Don’t check the test until that amount of time has passed.
    (c).  Take the test later in the day. For the most accurate results, take the test right after you get up in the morning. That’s when your urine is the most concentrated, making HCG easier to find.
  2. Could medicine change the test results?
    Fertility medication or other medicine that contains HCG might affect home pregnancy test results. Most medicines, though, including antibiotics and birth control pills, don’t affect the accuracy of home pregnancy tests.
  3. What happens next?
    Based on the test results, consider taking the following steps:
    (a). Your home pregnancy test is positive, or you’ve taken a few home pregnancy tests and gotten mixed results. Make an appointment with your health care provider. You might need a blood test or ultrasound to confirm the pregnancy. The sooner a pregnancy is confirmed, the sooner prenatal care can begin.
    (b).  Your home pregnancy test is negative. If your period doesn’t begin, take the test again in a few days or in one week. It’s especially important to do this if you took the test before or right after a missed period.
    (c).  You continue to get negative test results, but your period doesn’t start. Or you still think you might be pregnant. Contact your health care provider. Your provider may suggest you take a blood test to check for pregnancy, which may be more accurate than a home test. Also, some health problems may lead to missed periods. If you’re not pregnant, your health care provider can help you find out what’s causing missed periods.
Additional information
Product No

FHC-AE103H

,

FHC-AEU103H

Packing Size

1 Test

,

100 Tests

,

3 Tests

,

40 Tests

,

20 tests

Shipping & Delivery