Surearly™ Digital Pregnancy Test HCGR001E
GUDID 08809408860191
Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display.
Sugentech Inc._Osong Branch
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| NIH Device Record Key | c380d91e-f4b7-44a6-b59b-bdf6e9cfc3bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surearly™ Digital Pregnancy Test |
| Version Model Number | SU-DR02-CG |
| Catalog Number | HCGR001E |
| Company DUNS | 694860936 |
| Company Name | Sugentech Inc._Osong Branch |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809408860191 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142754
FDA Product Code
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-07-06 |
| Device Publish Date | 2018-11-26 |
Devices Manufactured by Sugentech Inc._Osong Branch
| 08809408860191 - Surearly™ Digital Pregnancy Test | 2023-07-06Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display. |
| 08809408860191 - Surearly™ Digital Pregnancy Test | 2023-07-06 Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a pla |
| 08809408860597 - Surearly™ Pregnancy Test Strip | 2023-07-06 Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and th |
| 08809408860870 - Surearly™ Digital Ovulation Test | 2020-11-03 Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone ( |
| 08809408860863 - Surearly™ Digital Ovulation Test | 2020-11-03 Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone ( |
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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