AccessGUDID - DEVICE: GoldN Easy to Use FSH Test (00850059915370)

GUDID

Device Identifier (DI) Information

Brand Name: GoldN Easy to Use FSH Test
Version or Model: GN011ST02-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GN011ST
Company Name: NOVODX Corporation

Primary DI Number: 00850059915370
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119046376 *Terms of Use

Device Description: The GoldN™ Easy to Use FSH Test is a rapid immunochromatographic assay for the qualitative detection of follicle-stimulating hormone (FSH) in urine to aid women in the assessment of the onset of menopause.

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?
65841	Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of follicle stimulating hormone (FSH) 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 intended to be used for self-testing by a layperson in the home or similar environment as an aid in the diagnosis of conditions related to reproductive health (e.g., menopause, infertility).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGA	Test, Follicle Stimulating Hormone (Fsh), 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 2 and 30 Degrees Celsius
Handling Environment Temperature: between 2 and 30 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 114f261a-6bb5-49f0-bac9-97726bc940e1
Public Version Date: November 06, 2025
Public Version Number: 2
DI Record Publish Date: January 24, 2025