Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
Sugentech, Inc.
Sugentech, Inc.
PMN#
GUDID#
Surearly SMART Ovulation Test Starter Kit
2026-05-08
Surearly SMART Ovulation Test - Surearly SMART Ovulation Test is an in-vitro diagnostic medical device designed for the semi-quantitative detection of two hormones in human urine: Luteinizing hormone (LH) and Progesterone metabolite (P3G). Utilizing a lateral-flow immunochromatographic principle, the assays enable the simultaneous measurement of both hormones using a single test stick in urine.The test aids in predicting user’s fertile days and confirming ovulation. Surearly SMART Ovulation Test can track and monitor the hormone level changes through the Surearly SMART and Surearly App. It is intended for self-testing at home.
2026-05-08
Surearly SMART - Surearly SMART is a self-testing in vitro diagnostic device for home-use that displayed qualitative or semi-quantitative results from a test stick that detects various hormones such as hCG, LH, FSH, etc in human urine. The firmware-driven Surearly SMART measures the color degree of the test stick using optical methods according to the visible light reflectance. The measured data is transmitted to the App via Bluetooth, and the analyzed results are transmitted back to the Surearly SMART and displayed.
2026-05-08
Surearly™ Pregnancy Test Strip - Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and the control and test regions are located in the middle of the strip. Users immerse the sample pad of the strip into the collected urine and see the test results from the colored lines appeared on the strip. The test results are interpreted by users according to the instructions for use.
2018-11-26
Surearly™ Digital Pregnancy Test - Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display.
2018-11-26
PettyPip - The pettyPip is a device for collecting 10 uL of whole blood and injecting it into the IVD device, such as POC or NPT devices. This device is composed of two parts; a Tip and a Plunger. The hole at the top end of the plunger provides sample collection through capillary action.
2025-05-15
Surearly SMART - Surearly SMART is a self-testing in-vitro diagnostic device that displayed qualitative or semi-quantitative results from a test stick that detects various hormones such as hCG, LH, FSH, etc. in human urine. The firmware-driven Surearly SMART measures the color degree of the test stick using optical methods according to the visible light reflectance. The measured data is transmitted to the Surearly SMART App via Bluetooth, and the analyzed results are transmitted back to the Surearly SMART and displayed.
2025-05-15
Surearly™ Digital Ovulation Test - Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only.
2020-10-26
Surearly™ Digital Ovulation Test - Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only.
2020-10-26
Surearly SMART Ovulation Test - The Surearly SMART Ovulation Test works by inserting the test stick into the test reader, which measures color changes on the test stick. It detects LH (10 mIU/mL or greater) and Progesterone metabolites (5 ug/mL or greater) in urine. Monoclonal LH antibodies and P3G-BSA conjugate with anti-P3G antibodies are immobilized on test lines 1 and 2 respectively. The test strip contains pre-dried antibodies with gold conjugates.When urine is absorbed, LH and P3G combine with antibody gold conjugates on the gold conjugate pad. The antigen-antibody complexes react with anti-LH antibody on test line 1 and P3G-BSA on test line 2, forming red or purple lines. The control line is displayed using goat anti-rabbit IgG antibody. Instead of confusing visual interpretation, Surearly SMART Ovulation Test provides easy-to-read and clear digital results both on the device and the App. The App also provides more information with hormone graph and additional messages to help your comprehensive management of hormone cycle.
2025-05-15
Surearly SMART Menopause Test - The Surearly SMART Menopause Test works by inserting the test stick into the Test reader, which measures color changes on the test stick. It detects FSH at a concentrationof 25 mIU/mL or greater. The test line utilizes a monoclonal FSH antibody and the test strip contains pre-dried antibodies with gold conjugates. When urine is absorbed, FSHcombines with antibody gold conjugates on the gold conjugate pad. The formed antigen-antibody complexes react with the anti-FSH antibody on the test line, resulting in red orpurple lines. The control line is displayed using goat anti-rabbit IgG antibody. Instead of confusing visual interpretation, the Surearly SMART Menopause Test provides easy-to-read and clear digital results both on the device and the App. The App also provides more information with hormone graphs and additional messages to help your comprehensive management of hormonal health.
2025-05-15
Surearly™ Digital Ovulation Test - Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only.
2020-10-26
Surearly™ Digital Ovulation Test - Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only.
2020-10-26