FDA.reportPublic FDA data

BD MAX™ Enteric Bacterial Panel

Primary DI
00382904429638
Brand
BD MAX™ Enteric Bacterial Panel
Company
BECTON, DICKINSON AND COMPANY
Model
442963
Catalog number
442963
Device description
Kit BD MAX Enteric Bacterial Panel
Published
2016-10-17
Public version status
Update
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
K140111000
K214122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140111000BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENTBecton, Dickinson and Company2014-05-06PCI
K214122000BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelBecton, Dickinson and Company2022-07-28PCI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904429638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904429638003829044296383829044296380382904429638

GMDN Terms#

Term, Definition table
TermDefinition
Multiple 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 one or more bacteria 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
Storage Environment Temperature2 Degrees Celsius25 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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