AccessGUDID - DEVICE: GoldN LH Ovulation Rapid Test Midstream (Urine)(25-Pack) (OTC) (00850059915424)

GUDID

Device Identifier (DI) Information

Brand Name: GoldN LH Ovulation Rapid Test Midstream (Urine)(25-Pack) (OTC)
Version or Model: GN013ST
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GN013ST25-US
Company Name: NOVODX Corporation

Primary DI Number: 00850059915424
Issuing Agency: GS1
Commercial Distribution End Date: February 26, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 119046376 *Terms of Use

Device Description: A rapid immunochromatographic assay for the qualitative detection of Luteinizing Hormone (LH) surge for the detection of ovulation and fertility. For over-the-counter use. The test reagent is exposed to urine, allowing urine to migrate through the absorbent test strip. The labeled antibody-dye conjugate binds to the LH in the specimen forming an antibody-antigen complex. This complex binds to the anti-LH antibody in the test region (T) and produces a colored line. In the absence of LH, there is no color line in the test region (T). The reaction mixture continues flowing through the absorbent device past the test region (T) and control region (C), producing a colored line, demonstrating that the test strip is functioning correctly. The test strip can accurately detect your LH surge when the concentration of LH is equal to or greater than 25mIU/ml.

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 Humidity: between 40 and 60 Percent (%) Relative Humidity
Handling Environment Temperature: between 2 and 30 Degrees Celsius
Storage Environment Temperature: between 2 and 30 Degrees Celsius
Storage 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: 2c53a299-a793-435f-94db-eebe028c84cc
Public Version Date: January 06, 2025
Public Version Number: 2
DI Record Publish Date: February 23, 2024