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Surearly SMART Ovulation Test

FDA UDI

Class I (US FDA UDI)

by Sugentech Inc._Osong Branch

Identity

Trade Name
Surearly SMART Ovulation Test FDA UDI
Generic Name
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical FDA UDI
Device Name
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. FDA UDI
Model / Reference
Surearly SMART Ovulation Test FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
08809408863482 FDA UDI
FDA Product Code
NGE FDA UDI
GMDN Term
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1485 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

Surearly SMART Ovulation Test by Sugentech Inc._Osong Branch — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sugentech Inc._Osong Branch

Sources (1)

  • FDA UDI f90377c3-1c56-442a-9faf-276c270118f4 35 fields · synced May 30, 2026