FSH

Basic Information

• Brand Name: FSH
• Primary DI: 00404847453553
• Version / Model: HYE-5355
• Catalog Number: HYE-5355
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• Labeler DUNS: 317134468
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-07
• Public Version: 1
• Public Version Date: 2021-06-15
• Public Version Status: New
• Public Device Record Key: b1d70c51-d791-4119-80f9-f0d8e156a508

Device Description

The DRG:HYBRId-XL FSH is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of follicle stimulating hormone in serum, heparin-, and EDTA-plasma.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
54186	Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of follicle stimulating hormone (FSH) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00404847453553	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius