One Step Menopausal Test

Basic Information

• Brand Name: One Step Menopausal Test
• Primary DI: B512210011
• Version / Model: 21001
• Catalog Number: 210-01
• Company Name: UNIVERSAL MEDITECH INC.
• Labeler DUNS: 080243910
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-15
• Public Version: 1
• Public Version Date: 2021-10-25
• Public Version Status: New
• Public Device Record Key: 74070bd8-d139-41fb-a3ee-f5a9887834de

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
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	862.1300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30512	Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test	A collection of reagents and other associated materials intended to be used for the qualitative and/or 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. This test is commonly used in the laboratory or in point-of-care analyses, and is also available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B512210011	HIBCC