VITEK® 2 AST-ST02

Basic Information

• Brand Name: VITEK® 2 AST-ST02
• Primary DI: 03573026554613
• Version / Model: VITEK® 2 AST-ST02
• Company Name: BIOMERIEUX , INC.
• Labeler DUNS: 086785110
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-09
• Public Version: 4
• Public Version Date: 2022-05-11
• Public Version Status: Update
• Public Device Record Key: f6ab7233-263e-4da2-bff9-6fe189527a0e

Device Description

The VITEK® 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus

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
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	866.1645	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	03573026552152	GS1		20	In Commercial Distribution
Primary	03573026554613	GS1

Premarket Submissions

Submission Number	Supplement Number
K110106	000
K111599	000
K111893	000
K111909	000
K111976	000
K112000	000
K112075	000
K112129	000
K112228	000
K121100	000
K121863	000
K122359	000
K131779	000
K132573	000

Storage Conditions

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