Device
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 Pro...
Manufacturer
Sugentech Inc._Osong Branch
Sugentech Inc._Osong Branch
Model: Surearly SMART Ovulation Test
Catalog: SLHN020E
DI: 08809408864199
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-08
Current Version: 2026-05-18
Description
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b32464bc-745b-454c-b3f3-cd9bd38eb236
Distribution Status:
In Commercial Distribution
DUNS Number:
694860936
Device Count:
20
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
08809408864328
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08809408864199
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 65947
Name: Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of luteinizing hormone (LH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment as an ovulation signal to optimise the chances of natural conception.
FDA Product Codes
NGE
Test, Luteinizing Hormone (Lh), Over The Counter