VITEK 2

GUDID 03573026605667

The DISPLAY is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacterial suspension. It is used for the Vitek instrument to prepare ID and AST test.

BIOMERIEUX , INC.

Photometer, absorbance/transmission, automated

• Primary Device ID: 03573026605667
• NIH Device Record Key: fd12a274-2050-46c6-aef6-b2b97d79fda0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK 2
• Version Model Number: 422220
• 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 -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026605667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192110

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: 2019-12-16
• Device Publish Date: 2019-12-06

On-Brand Devices [VITEK 2]

• 03573026605667: The DISPLAY is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacteri
• 03573026605674: VITEK DENSICHEK CONNECTIVITY BASE Kit that include one pod and one connecrtivity base