Enteric Bacterial Panel Diluent for BD COR™ System 445279

GUDID 00382904452797

Enteric Bacterial Panel Diluent for BD COR™ System

BECTON, DICKINSON AND COMPANY

Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, reagent

• Primary Device ID: 00382904452797
• NIH Device Record Key: 6e9206cc-ece0-4b29-b9ba-dbc88857f35f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enteric Bacterial Panel Diluent for BD COR™ System
• Version Model Number: 445279
• Catalog Number: 445279
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 4
• 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: 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

Customer Support Contacts

• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Storage Environment Temperature: Between 2 Degrees Celsius and 33 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904452797 [Unit of Use]
GS1	30382904452798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250358

FDA Product Code

• OOI: real time Nucleic acid amplification system

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: 2025-12-17
• Device Publish Date: 2025-12-09

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