FDA.reportPublic FDA data

BD MAX™ Enteric Parasite Panel (US/CAN)

Primary DI
00382904433802
Brand
BD MAX™ Enteric Parasite Panel (US/CAN)
Company
Geneohm Sciences Canada Inc
Model
443380
Catalog number
443380
Device description
BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer
Published
2016-05-19
Public version status
Update
Distribution status
Not 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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143648000BD MAX Enteric Parasite Panel, BD MAX InstrumentBecton, Dickinson and Company2015-08-25PCH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904433802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904433802003829044338023829044338020382904433802

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gastrointestinal pathogen 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 types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, 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
255438483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382904433789BD MAX™ Enteric Bacterial Panel (US/CAN)4433784433782016-07-27
00382904375065BD MAX™ RNA-34375064375062018-05-25
00382904429539BD MAX™ MRSA4429534429532016-07-27
00382904416652BD GeneOhm™ VanR Assay4416654416652016-05-19
00382904414481BD GeneOhm™ StaphSR assay 48 TestsA4414484414482016-08-10
00382904416379BD GeneOhm™ MRSA ACP Assay (48 tests)4416374416372016-08-09
00382904416386BD GeneOhm™ MRSA ACP Lysis Kit4416384416382016-08-10
00382904416393BD GeneOhm™ MRSA ACP Assay4416394416392016-08-09
00382904438241BD MAX™ CT/GC/TV4438244438242016-10-17

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Primary DI, Brand, Company table
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00875197005684cobas® Cdiff Control KitRoche Molecular Systems, Inc.OOI2026-02-23
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20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCOOI2026-01-14
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