Surearly™ Pregnancy Test Strip
GUDID 08809408860597
Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and the control and test regions are located in the middle of the strip. Users immerse the sample pad of the strip into the collected urine and see the test results from the colored lines appeared on the strip. The test results are interpreted by users according to the instructions for use.
Sugentech Inc._Osong Branch
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical| Primary Device ID | 08809408860597 |
| NIH Device Record Key | 62500e12-db8d-4dbb-96bf-f4405a5d638c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surearly™ Pregnancy Test Strip |
| Version Model Number | HCGS003E |
| Company DUNS | 694860936 |
| Company Name | Sugentech Inc._Osong Branch |
| Device Count | 3 |
| 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 | 08809408860597 [Primary] |
| GS1 | 08809408860610 [Unit of Use] |
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 | 2023-07-06 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 | 2023-07-06Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and the control and test regions are located in the middle of the strip. Users immerse the sample pad of the strip into the collected urine and see the test results from the colored lines appeared on the strip. The test results are interpreted by users according to the instructions for use. |
| 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.