VITEK®2

GUDID 03573026555504

VITEK®2 software 9.01.0, advanced software to run your VITEK®2 system

BIOMERIEUX , INC.

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

• Primary Device ID: 03573026555504
• NIH Device Record Key: 4aec6f19-93f8-414c-955a-9596387c1751
• Commercial Distribution Discontinuation: 2020-06-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VITEK®2
• Version Model Number: 9.01.0
• 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: true
• 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	03573026555504 [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: 3
• Public Version Date: 2022-03-01
• Device Publish Date: 2018-12-07

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