Elecsys Testosterone II

Basic Information

• Brand Name: Elecsys Testosterone II
• Primary DI: 07613336170557
• Version / Model: 08946353190
• Catalog Number: 08946353190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-21
• Public Version: 2
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 117f4fa1-9c73-4a96-b56a-3047d63edc28

Device Description

Testosterone G2 Elecsys cobas e 100 V2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: 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
61077	Total testosterone IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total testosterone in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613336170557	GS1

Premarket Submissions

Submission Number	Supplement Number
K211685	000