Device
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 suc...
Manufacturer
Sugentech Inc._Osong Branch
Sugentech Inc._Osong Branch
Model: Surearly SMART
Catalog: SSFD001E
DI: 08809408864113
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-08
Current Version: 2026-05-18
Description
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7343860e-2485-4f68-a215-ac814ee0111c
Distribution Status:
In Commercial Distribution
DUNS Number:
694860936
Device Count:
1
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
08809408864113
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08809408863499
Item #2 - Device ID Type:
Previous
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 42625
Name: Photometric/spectroscopic immunoassay analyser IVD
Definition:
An electrically-powered instrument intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card), after vehicle exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in the clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by healthcare professionals for rapid in vitro diagnostic measurements [e.g., lateral flow immunochromatographic (ICT) test] at the point-of-care or in the laboratory.
FDA Product Codes
NGE
Test, Luteinizing Hormone (Lh), Over The Counter
NGA
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
2
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
30
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Keep away from direct sunlight, moisture and heat