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

Devices Manufactured by BECTON, DICKINSON AND COMPANY

00382904448721 - BD Enteric Bacterial Panel plus for BD COR™ System2025-12-17 BD Enteric Bacterial Panel plus for BD COR™ System
00382904448738 - BD Enteric Bacterial Panel for BD COR™ System2025-12-17BD Enteric Bacterial Panel for BD COR™ System
00382904448738 - BD Enteric Bacterial Panel for BD COR™ System2025-12-17 BD Enteric Bacterial Panel for BD COR™ System
00382904452797 - Enteric Bacterial Panel Diluent for BD COR™ System2025-12-17 Enteric Bacterial Panel Diluent for BD COR™ System
50382903835893 - BD Nexiva™ Diffusics™ Closed IV Catheter System2025-09-17 NEXIVA DIFFUSICS w/MaxZero 18G X 1.75 IN
30382903835967 - BD Nexiva™ Diffusics™ Closed IV Catheter System2025-09-17 NEXIVA DIFFUSICS w/MaxZero 22G X 1.00 IN
30382902560921 - BD Veritor System for Rapid Detection of SARS-CoV-22025-08-29 Veritor SARS-CoV2 assay Gen 2
30382902561386 - BD Veritor SARS-CoV-2 Control Swab Set2025-08-29 Veritor COVID Gen 2 control swab set
00382904413576 - BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens2025-08-25 BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens Contains: 100 each sterile polyester-tipped cleaning swab,
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.