Free Testosterone ELISA

Basic Information

• Brand Name: Free Testosterone ELISA
• Primary DI: 00840239046383
• Version / Model: EIA-4638
• Catalog Number: EIA-4638
• Company Name: DRG International Inc
• Labeler DUNS: 075150847
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-07
• Public Version: 3
• Public Version Date: 2023-07-26
• Public Version Status: Update
• Public Device Record Key: b9f3e0fc-ba79-4302-8a62-295657709c3a

Device Description

For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human serum. For in vitro diagnostic use only.

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: No
• 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
CDZ	RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE	Clinical Chemistry	862.1680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54181	Free testosterone IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free testosterone 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	00840239046383	GS1

Customer Contacts

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

Storage Conditions

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