AccessGUDID - DEVICE: DAVID Ovulation Test Midstream (06938444980074)

GUDID

Device Identifier (DI) Information

Brand Name: DAVID Ovulation Test Midstream
Version or Model: 80074
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RH-LH-B
Company Name: Equinox Biotech Co., Ltd.

Primary DI Number: 06938444980074
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 545868502 *Terms of Use

Device Description: The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use.

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:	Yes
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
Storage Environment Temperature: between 35.6 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bf85bee9-b224-4e77-be4b-3cc5530bb27c
Public Version Date: January 16, 2023
Public Version Number: 5
DI Record Publish Date: August 08, 2016