FDA.reportPublic FDA data

BD MAX™ Extended Enteric Bacterial Panel

Primary DI
00382904438128
Brand
BD MAX™ Extended Enteric Bacterial Panel
Company
BECTON, DICKINSON AND COMPANY
Model
443812
Catalog number
443812
Device description
Kit BD MAX EXT Enteric Bacterial Panel
Published
2019-01-03
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
PCHGastrointestinal pathogen panel multiplex nucleic acid-based assay system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170308000
K214122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170308000BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company2017-05-02PCH
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
00382904438128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904438128003829044381283829044381280382904438128

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
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30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332940009489XpertCEPHEIDPCH2026-01-30
30382904452798Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYPCH2025-12-09
00382904448721BD Enteric Bacterial Panel plus for BD COR™ SystemBECTON, DICKINSON AND COMPANYPCH2025-12-09
00382904448738BD Enteric Bacterial Panel for BD COR™ SystemBECTON, DICKINSON AND COMPANYPCH2025-12-09
15420045517486Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517493Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517509Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517516Panther Fusion®Hologic, Inc.PCH2025-10-07
04053228048381QIAstat-Dx® GI Panel 2 Mini BQIAGEN GmbHPCH2025-03-28
00815381020888BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel MidBIOFIRE DIAGNOSTICS, LLCPCH2025-02-18
00815381020963BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel MidBIOFIRE DIAGNOSTICS, LLCPCH2025-02-18
04053228049166QIAstat-Dx® GI Panel 2 Mini B&VQIAGEN GmbHPCH2025-02-18
09351179004070EasyScreen™ Gastrointestinal Parasite PCR Positive ControlGENETIC SIGNATURES LIMITEDPCH2024-06-18
04053228043249QIAstat-Dx® Gastrointestinal Panel 2QIAGEN GmbHPCH2024-06-17
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYPCH2024-06-07
00382904431594BD Pre-warm HeaterBECTON, DICKINSON AND COMPANYPCH2024-03-19
00382904439859BD MAX™ Enteric Viral PanelBECTON, DICKINSON AND COMPANYPCH2020-02-19
00840487101520Enteric Pathogens (EP) Nucleic Acid Test CartridgeLUMINEX CORPORATIONPCH2019-12-05
00840487101544Enteric Pathogens (EP) Amplification TrayLUMINEX CORPORATIONPCH2019-12-05
00840487101551Enteric Pathogens (EP) Extraction TrayLUMINEX CORPORATIONPCH2019-12-05
00840487101568Enteric Pathogens (EP) Stool Sample Preparation KitLUMINEX CORPORATIONPCH2019-12-05
00851034007004BioCode MDx 3000APPLIED BIOCODE, INC.PCH2018-10-15
00851034007011Gastrointestinal Pathogen Panel (GPP) KitAPPLIED BIOCODE, INC.PCH2018-10-15
07332940000974Xpert NorovirusCEPHEIDPCH2018-01-29
B178GBSBPP100Stool Bacterial Pathogens PanelGREAT BASIN SCIENTIFIC, INC.PCH2017-07-24
00382904429607BD MAX™ Enteric Parasite PanelBECTON, DICKINSON AND COMPANYPCH2016-10-17
00382904429638BD MAX™ Enteric Bacterial PanelBECTON, DICKINSON AND COMPANYPCH2016-10-17
B178GBSTEC100Shiga Toxin Direct TestGREAT BASIN SCIENTIFIC, INC.PCH2016-09-23
00857573006041Enteric Pathogens (EP) Nucleic Acid Test CartridgeNANOSPHERE, INC.PCH2016-09-23
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