VITEK® 2 KB UPDATE V2S

GUDID 03573026626471

Knowledge Base Update for VITEK2 Software

BIOMERIEUX , INC.

Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD

• Primary Device ID: 03573026626471
• NIH Device Record Key: 7341d905-409c-4740-bcfc-1b3bb9a22e26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK® 2 KB UPDATE V2S
• Version Model Number: 9.04
• 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	03573026626471 [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: 2023-09-06
• Device Publish Date: 2023-08-29

Devices Manufactured by BIOMERIEUX , INC.

• 03573026636357 - VITEK® 2 AST-N814: 2023-12-14 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026635978 - VITEK® 2 AST-N809: 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636142 - VITEK® 2 AST-N811: 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636296 - VITEK® 2 AST-N812: 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636319 - VITEK® 2 AST-N813: 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636333 - VITEK® 2 AST-XN33: 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636128 - VITEK® 2 AST-N810: 2023-11-09 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 03573026636067 - VITEK® 2 AST-N804: 2023-10-04 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin