VITEK® 2 AST-N804

GUDID 03573026636067

VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli

BIOMERIEUX , INC.

General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD

• Primary Device ID: 03573026636067
• NIH Device Record Key: 964a1291-f98d-40cd-9aa8-a3330bcfb1f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK® 2 AST-N804
• Version Model Number: VITEK® 2 AST-N806
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026636050 [Primary]
GS1	03573026636067 [Package]; Contains: 03573026636050; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040845
• Premarket Notification: K072038

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: 2023-10-04
• Device Publish Date: 2023-09-26

On-Brand Devices [VITEK® 2 AST-N804]

• 03573026634797: VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to dete
• 03573026636081: VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to dete
• 03573026636067: VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to dete