Surearly™ Digital Pregnancy Test HCGR001E

GUDID 08809408860191

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Primary Device ID	08809408860191
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

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	08809408860191 [Primary]

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

Steralize Prior To Use	false
Device Is Sterile	false

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 (

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