VITEK® 2 YST

Basic Information

• Brand Name: VITEK® 2 YST
• Primary DI: 03573026529697
• Version / Model: VITEK® 2 YST
• Company Name: BIOMERIEUX , INC.
• Labeler DUNS: 086785110
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-02
• Public Version: 2
• Public Version Date: 2022-05-10
• Public Version Status: Update
• Public Device Record Key: a0a2904f-87f0-41ab-9b63-a126d907cbdc

Device Description

The VITEK® 2 YST Identification Card is intended for use with the VITEK 2 to determine ID of clinically important yeast and yeast-like organisms

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
JXB	KIT, IDENTIFICATION, YEAST	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30666	Multiple Candida/yeast species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of Candida and/or yeast isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03573026131937	GS1		20	In Commercial Distribution
Primary	03573026529697	GS1

Storage Conditions

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