VITEK® 2 AST-YS09

Basic Information

• Brand Name: VITEK® 2 AST-YS09
• Primary DI: 03573026619350
• Version / Model: VITEK® 2 AST-YS09
• Company Name: BIOMERIEUX , INC.
• Labeler DUNS: 086785110
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-05
• Public Version: 2
• Public Version Date: 2022-05-10
• Public Version Status: Update
• Public Device Record Key: c3cadde2-7540-48db-b672-862f0097f1c2

Device Description

The VITEK 2 ® Yeast Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant yeast.

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: 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
NGZ	SUSCEPTIBILITY TEST PLATE, ANTIFUNGAL	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58605	General-microorganism antimicrobial susceptibility culture medium IVD	A non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03573026619268	GS1		20	In Commercial Distribution
Primary	03573026619350	GS1

Premarket Submissions

Submission Number	Supplement Number
K092454	000
K133817	000
K133952	000
K151817	000
K151923	000

Storage Conditions

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