Surearly SMART Ovulation Test

GUDID 08809408863482

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.

Sugentech Inc._Osong Branch

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Primary Device ID08809408863482
NIH Device Record Keyf90377c3-1c56-442a-9faf-276c270118f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurearly SMART Ovulation Test
Version Model NumberSurearly SMART Ovulation Test
Company DUNS694860936
Company NameSugentech Inc._Osong Branch
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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
GS108809408863482 [Primary]
GS108809408863529 [Unit of Use]

FDA Product Code

NGETest, Luteinizing Hormone (Lh), 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

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