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 ID00382904452797
NIH Device Record Key6e9206cc-ece0-4b29-b9ba-dbc88857f35f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnteric Bacterial Panel Diluent for BD COR™ System
Version Model Number445279
Catalog Number445279
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904452797 [Unit of Use]
GS130382904452798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOIreal time Nucleic acid amplification system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-17
Device Publish Date2025-12-09

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