AccessGUDID - DEVICE: Surearly™ Digital Ovulation Test (08809408860245)

GUDID

Device Identifier (DI) Information

Brand Name: Surearly™ Digital Ovulation Test
Version or Model: SU-DR01-LH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HLHM020E
Company Name: Sugentech Inc._Osong Branch

Primary DI Number: 08809408860245
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 694860936 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54255	Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of luteinizing hormone (LH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGE	Test, Luteinizing Hormone (Lh), Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f1f8fe1c-cead-41ad-bd77-b50c9efa25a5
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: October 26, 2020