VITEK®2

GUDID 03573026145804

VITEK®2 60 is an automated system that performs bacterial ID and AST. A total of 60 ID and/or AST cards can be processed simultaneously per run.

BIOMERIEUX , INC.

Microorganism identification/antimicrobial-susceptibility analyser IVD

• Primary Device ID: 03573026145804
• NIH Device Record Key: 08e00e75-0cf8-4fe3-bba4-6a6994f725f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK®2
• Version Model Number: 27220R
• 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 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026145804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: N50510

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]

• 03573026609399: CD WITH 9.02 software version
• 03573026463533: VITEK 2.0 0.45% SALINE INDIVIDUAL BAG
• 03573026555504: VITEK®2 software 9.01.0, advanced software to run your VITEK®2 system
• 03573026619060: VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
• 03573026206765: VITEK®2 60 is an automated system that performs bacterial ID and AST. A total of 60 ID and/o
• 03573026145804: VITEK®2 60 is an automated system that performs bacterial ID and AST. A total of 60 ID and/o
• 03573026206789: VITEK®2 XL is an automated system that performs large volumes of bacterial ID & AST testings