Enteric Bacterial Panel Diluent for BD COR™ System

Basic Information

• Brand Name: Enteric Bacterial Panel Diluent for BD COR™ System
• Primary DI: 30382904452798
• Version / Model: 445279
• Catalog Number: 445279
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2025-12-09
• Public Version: 1
• Public Version Date: 2025-12-17
• Public Version Status: New
• Public Device Record Key: 6e9206cc-ece0-4b29-b9ba-dbc88857f35f

Device Description

Enteric Bacterial Panel Diluent for BD COR™ System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOI	real time Nucleic acid amplification system	Clinical Chemistry	862.2570	2
PCI	Gastrointestinal bacterial panel multiplex nucleic acid-based assay system	Microbiology	866.3990	2
PCH	Gastrointestinal pathogen panel multiplex nucleic acid-based assay system	Microbiology	866.3990	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47382	Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from multiple bacteria genera associated with gastrointestinal diseases, in a clinical specimen. Bacteria detected may include Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Bacillus and/or Vibrio species.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00382904452797	GS1
Primary	30382904452798	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K250358	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 33 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: This way up
• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, handle with care