GenaCheck® FSH At-Home Menopause Test

Basic Information

• Brand Name: GenaCheck® FSH At-Home Menopause Test
• Primary DI: 00810143620214
• Version / Model: N/A
• Company Name: Genabio Diagnostics Inc.
• Labeler DUNS: 118586095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-26
• Public Version: 1
• Public Version Date: 2025-03-06
• Public Version Status: New
• Public Device Record Key: 7323be90-cce1-4bee-9b22-88ed19d6695c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	862.1300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810143620214	GS1