VITEK 2 ® AST-YS09

GUDID 03573026619268

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

BIOMERIEUX , INC.

General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD

Primary Device ID	03573026619268
NIH Device Record Key	c3cadde2-7540-48db-b672-862f0097f1c2
Commercial Distribution Status	In Commercial Distribution
Brand Name	VITEK 2 ® AST-YS09
Version Model Number	VITEK®2 AST-YS09
Company DUNS	086785110
Company Name	BIOMERIEUX , INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026619268 [Package] Contains: 03573026619350 Package: [20 Units] In Commercial Distribution
GS1	03573026619350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092454

FDA Product Code

NGZ	SUSCEPTIBILITY TEST PLATE, ANTIFUNGAL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-04-15
Device Publish Date	2019-04-05

Devices Manufactured by BIOMERIEUX , INC.

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