BD Enteric Bacterial Panel for BD COR™ System 444873

GUDID 00382904448738

BD Enteric Bacterial Panel for BD COR™ System

BECTON, DICKINSON AND COMPANY

Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00382904448738
NIH Device Record Key35005821-d4e9-466e-a1b9-19e6e36b85e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Enteric Bacterial Panel for BD COR™ System
Version Model Number444873
Catalog Number444873
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, SpecifyBetween 0 and 0 *P405 – Store locked up.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904448738 [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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