Identity
- Trade Name
- Surearly™ Digital Ovulation Test FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only. FDA UDI
- Model / Reference
- SU-DR01-LH FDA UDI
- Description
- Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only. FDA UDI
Identifiers
- Catalog Number
- HLHM007E FDA UDI
- Primary DI / UDI-DI
- 08809408860214 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
No
FDA UDI
Category: Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Surearly™ Digital 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.
- AMPLIM — AMPLIM, LLC · Class II
- Natalist Ovulation Test — Equinox Biotech Co., Ltd. · Class I
- AMPLIM — AMPLIM, LLC · Class II
- INSTANT-VIEW LH Ovulation Predicting Cassette Test — Alfa Scientific Designs, Inc. · Class I
- Mosie Baby Ovulation Test — GERMAINE LABORATORIES, INC. · Class I
- FERTICARE — Weihai Kangzhou Biotechnology Engineering Co., Ltd · Class I
- Modern Fertility Ovulation Test — MODERN HEALTH · Class I
- Natural Cycles — Natural Cycles Nordic AB · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sugentech Inc._Osong Branch
Sources (1)
- FDA UDI 6e06b152-fc5d-41dc-9632-3b70463a4bf5 36 fields · synced May 30, 2026