Free Testosterone ELISA

Basic Information

• Brand Name: Free Testosterone ELISA
• Primary DI: B24211FTEHUE010
• Version / Model: 11-FTEHU-E01
• Catalog Number: 11-FTEHU-E01
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• Labeler DUNS: 784143778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-02
• Public Version: 2
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 131aaf6f-b6f1-4d76-9523-9a4082246177

Device Description

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

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: 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
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	B24211FTEHUE010	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K030730	000

Storage Conditions

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