VIDAS® TROPONIN I Ultra

Basic Information

• Brand Name: VIDAS® TROPONIN I Ultra
• Primary DI: 03573026229115
• Version / Model: 30448-01
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2020-05-14
• Public Version Status: Update
• Public Device Record Key: 794c6708-9936-45da-bd83-8814cb2a0ac5
• Distribution End Date: 2018-08-29

Device Description

VIDAS ® Troponin I Ultra (TNIU) is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in human serum or plasma.

Device Characteristics

• Single Use: No
• 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
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54009	Troponin I 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 troponin I 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	03573026229115	GS1

Storage Conditions

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