VITEK®2

GUDID 03573026609399

CD WITH 9.02 software version

BIOMERIEUX , INC.

Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated

• Primary Device ID: 03573026609399
• NIH Device Record Key: 115c307b-0e21-4933-9cf4-736fadf97a86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK®2
• Version Model Number: 9.02.0
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026609399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103752

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-20
• Device Publish Date: 2019-06-12

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
• 03573026553968: VITEK ® 2 software 8.01 update, advanced software to run your VITEK ® 2 system
• 03573026145842: VITEK®2 XL is an automated system that performs large volumes of bacterial ID & AST testings