Surearly SMART Ovulation Test

Primary DI
08809408863482
Brand
Surearly SMART Ovulation Test
Company
Sugentech Inc._Osong Branch
Model
Surearly SMART Ovulation Test
Device description
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.
Published
2025-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NGETest, Luteinizing Hormone (Lh), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGETest, Luteinizing Hormone (Lh), Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809408863482PrimaryGS10
08809408863529Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809408863482088094088634828809408863482
08809408863529088094088635298809408863529

GMDN Terms#

Term, Definition table
TermDefinition
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinicalA 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 used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep away from direct sunlight, moisture and heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-526-0943info@sugentech.com

Regulatory Flags#

DUNS number
694860936
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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08809408864199Surearly SMART Ovulation TestSurearly SMART Ovulation TestSLHN020E2026-05-08
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08809408863499Surearly SMARTSurearly SMART (SSMD001E)2025-05-15
08809408863505PettyPipPettyPipCT10300E2025-05-15
08809408860191Surearly™ Digital Pregnancy TestSU-DR02-CGHCGR001E2018-11-26
08809408860597Surearly™ Pregnancy Test StripHCGS003E2018-11-26
08809408863475Surearly SMART Menopause TestSurearly SMART Menopause Test2025-05-15
08809408860870Surearly™ Digital Ovulation TestSU-DR01-LHHLHM007E2020-10-26
08809408860863Surearly™ Digital Ovulation TestSU-DR01-LHHLHM020E2020-10-26

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Primary DI, Brand, Company table
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08809408864304Surearly SMART Ovulation Test Starter KitSugentech Inc._Osong BranchNGE2026-05-08
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