Surearly SMART

GUDID 08809408863499

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.

Sugentech Inc._Osong Branch

Immunoassay reagent vehicle reader IVD
Primary Device ID08809408863499
NIH Device Record Key92f50e63-1844-43f3-8151-cb8df69815e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurearly SMART
Version Model NumberSurearly SMART (SSMD001E)
Company DUNS694860936
Company NameSugentech Inc._Osong Branch
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com
Phone1-800-526-0943
Emailinfo@sugentech.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight, moisture and heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS108809408863499 [Primary]

FDA Product Code

NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-23
Device Publish Date2025-05-15

Devices Manufactured by Sugentech Inc._Osong Branch

08809408863475 - Surearly SMART Menopause Test2025-05-23 The Surearly SMART Menopause Test works by inserting the test stick into the Test reader, which measures color changes on the te
08809408863482 - Surearly SMART Ovulation Test2025-05-23 The Surearly SMART Ovulation Test works by inserting the test stick into the test reader, which measures color changes on the te
08809408863499 - Surearly SMART2025-05-23Surearly 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.
08809408863499 - Surearly SMART2025-05-23 Surearly SMART is a self-testing in-vitro diagnostic device that displayed qualitative or semi-quantitative results from a test
08809408863505 - PettyPip2025-05-23 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. T
08809408860191 - Surearly™ Digital Pregnancy Test2023-07-06 Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a pla
08809408860597 - Surearly™ Pregnancy Test Strip2023-07-06 Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and th
08809408860870 - Surearly™ Digital Ovulation Test2020-11-03 Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (
08809408860863 - Surearly™ Digital Ovulation Test2020-11-03 Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (
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