INSTANT-VIEW FSH Cassette Test

Basic Information

• Brand Name: INSTANT-VIEW FSH Cassette Test
• Primary DI: 10796918000139
• Version / Model: 02-2562
• Company Name: ALFA SCIENTIFIC DESIGNS, INC.
• Labeler DUNS: 176391167
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2019-05-01
• Public Version Status: Update
• Public Device Record Key: 70ae6247-0b8d-4c73-975c-79b99792b44a

Device Description

INSTANT-VIEW FSH Cassette Test

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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	10796918000139	GS1
Unit of Use	00796918000132	GS1