VITEK®2 Compact

GUDID 03573026220631

VITEK® 2 COMPACT 15 is an automated system that performs bacterial ID and AST. A total of 15 ID and/or AST cards can be processed simultaneously per run.

BIOMERIEUX , INC.

Microorganism identification/antimicrobial-susceptibility analyser IVD

• Primary Device ID: 03573026220631
• NIH Device Record Key: caa330fd-d1be-487d-9dcc-3195348a207c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK®2 Compact
• Version Model Number: 27415R
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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 -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026220631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050002

FDA Product Code

• LON: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-08-02
• Device Publish Date: 2016-09-14

On-Brand Devices [VITEK®2 Compact]

• 03573026220631: VITEK® 2 COMPACT 15 is an automated system that performs bacterial ID and AST. A total of 15 I
• 03573026147501: VITEK® 2 COMPACT 60 is an automated system that performs bacterial ID & AST. A total of 60 ID
• 03573026147495: VITEK® 2 COMPACT 30 is an automated system that performs bacterial ID and AST. A total of 30 I