Surearly™ Pregnancy Test Strip

GUDID 08809408860597

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

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 Issuing Agency	Device ID
GS1	08809408860597 [Primary]
GS1	08809408860610 [Unit of Use]

LCX	Kit, Test, Pregnancy, Hcg, Over The Counter

Steralize Prior To Use	false
Device Is Sterile	false

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 (

Mark Image Registration \| Serial	Company Trademark Application Date
SUREARLY 88213082 not registered Dead/Abandoned	Sugentech, Inc. 2018-11-30