FDA.reportPublic FDA data

BD Enteric Bacterial Panel for BD COR™ System

Primary DI
00382904448738
Brand
BD Enteric Bacterial Panel for BD COR™ System
Company
BECTON, DICKINSON AND COMPANY
Model
444873
Catalog number
444873
Device description
BD Enteric Bacterial Panel for BD COR™ System
Published
2025-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIreal time Nucleic acid amplification system
PCHGastrointestinal pathogen panel multiplex nucleic acid-based assay system
PCIGastrointestinal bacterial panel multiplex nucleic acid-based assay system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemMicrobiology2
PCIGastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250358000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250358000BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR SystemBecton, Dickinson and Company2025-10-31PCI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904448738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904448738003829044487383829044487380382904448738

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple bacteria genera associated with gastrointestinal diseases, in a clinical specimen, using a nucleic acid technique (NAT). Bacteria detected may include Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Bacillus and/or Vibrio species.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00P403+P233: Store in a well-ventilated place. Keep container tightly closed
Special Storage Condition, Specify00P405 – Store locked up.
Special Storage Condition, Specify00This way up
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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30382903678786BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes3678783678782016-07-28
30382903679639BD Vacutainer® PST™ Lithium HeparinN (LH) Blood Collection Tubes3679633679632016-07-28
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30382903679615BD Vacutainer® PST™ Gel and Lithium HeparinN 65 Units3679613679612016-07-28
30382903679622BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units3679623679622016-07-28
30382903678748BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes3678743678742016-07-28
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