Liofilchem Antibiotic Disc $9242 Cartridge

GUDID 18055182878571

LIOFILCHEM SRL

Antibacterial susceptibility testing disc IVD

• Primary Device ID: 18055182878571
• NIH Device Record Key: 5256da96-dfb8-477e-923f-fe566c9aee65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liofilchem Antibiotic Disc
• Version Model Number: Ceftobiprole BPR 5 µg
• Catalog Number: $9242 Cartridge
• Company DUNS: 435342134
• Company Name: LIOFILCHEM SRL
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055182878574 [Primary]
GS1	18055182878571 [Package]; Contains: 08055182878574; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250885

FDA Product Code

• JWY: Manual Antimicrobial Susceptibility Test Systems

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: 2025-07-23
• Device Publish Date: 2025-07-15

On-Brand Devices [Liofilchem Antibiotic Disc]

• 18055182878571: Ceftobiprole BPR 5 µg
• 08055182878567: Ceftobiprole BPR 5 µg