AccessGUDID - DEVICE: GoldN Easy to Use Ovulation Test (00850059915646)

GUDID

Device Identifier (DI) Information

Brand Name: GoldN Easy to Use Ovulation Test
Version or Model: GN013ST10-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GN013ST
Company Name: NOVODX Corporation

Primary DI Number: 00850059915646
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119046376 *Terms of Use

Device Description: The GoldNTM Easy to Use Ovulation Test is a rapid chromatographic immunoassay for the qualitative detection of Luteinizing Hormone (LH) surge in urine to predict the time of ovulation. The test is intended for women who want to conceive. For in vitro diagnostic use. For over-the-counter 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: No 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
Handling Environment Humidity: between 40 and 60 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 91a39451-ea83-43c9-9aa2-48cd289f7ea8
Public Version Date: November 06, 2025
Public Version Number: 3
DI Record Publish Date: February 22, 2024