VITEK® COMPACT PRO

GUDID 03573026615499

VITEK COMPACT PRO is an automated system that performs bacterial ID and AST. minimum, a total of 15 ID and/or AST cards can be processed simultaneously per run. can be extended to 30 or 60.

BIOMERIEUX , INC.

Microorganism identification/antimicrobial-susceptibility analyser IVD

• Primary Device ID: 03573026615499
• NIH Device Record Key: 2d8a4dbd-f4c0-4d51-a549-215b6a883ef4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITEK® COMPACT PRO
• Version Model Number: VTKE00
• 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 -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026615499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234012

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: 2025-05-23
• Device Publish Date: 2025-05-15

Devices Manufactured by BIOMERIEUX , INC.

• 03573026615499 - VITEK® COMPACT PRO: 2025-05-23VITEK COMPACT PRO is an automated system that performs bacterial ID and AST. minimum, a total of 15 ID and/or AST cards can be processed simultaneously per run. can be extended to 30 or 60.
• 03573026615499 - VITEK® COMPACT PRO: 2025-05-23 VITEK COMPACT PRO is an automated system that performs bacterial ID and AST. minimum, a total of 15 ID and/or AST cards can be
• 03573026618285 - VITEK: 2025-05-23 Vitek 2 software V10
• 03573026641337 - VITEK® 2 AST-N815: 2024-11-21 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
• 00860007326905 - VITEK® REVEAL™: 2024-10-17 The VITEK REVEAL Instrument is a benchtop instrument that processes up to four AST tests . Installation and operating details f
• 00860007326912 - VITEK® REVEAL™ SEALER: 2024-10-17 The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate.
• 03573026638900 - VITEK® REVEAL™ SENSOR PANEL: 2024-10-17 The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria
• 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