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

• 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

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