Surearly™ Digital Ovulation Test HLHM007E
GUDID 08809408860870
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.
Sugentech Inc._Osong Branch
Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 08809408860870 |
| NIH Device Record Key | 6e06b152-fc5d-41dc-9632-3b70463a4bf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surearly™ Digital Ovulation Test |
| Version Model Number | SU-DR01-LH |
| Catalog Number | HLHM007E |
| Company DUNS | 694860936 |
| Company Name | Sugentech Inc._Osong Branch |
| Device Count | 7 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com | |
| Phone | 1-800-526-0943 |
| info@sugentech.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809408860214 [Primary] |
| GS1 | 08809408860870 [Unit of Use] |
FDA Product Code
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-03 |
| Device Publish Date | 2020-10-26 |
On-Brand Devices [Surearly™ Digital Ovulation Test]
| 08809408860863 | Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determ |
| 08809408860870 | Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determ |
Trademark Results [Surearly]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUREARLY 88213082 not registered Dead/Abandoned |
Sugentech, Inc. 2018-11-30 |
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