FDA.reportPublic FDA data

BD MAX™ RNA-3

Primary DI
00382904375065
Brand
BD MAX™ RNA-3
Company
Geneohm Sciences Canada Inc
Model
437506
Catalog number
437506
Device description
BD MAX™ RNA-3
Published
2018-05-25
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
JJHCLINICAL SAMPLE CONCENTRATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904375065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904375065003829043750653829043750650382904375065

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

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
Premarket exempt
true
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
00382904429539BD MAX™ MRSA4429534429532016-07-27
00382904416652BD GeneOhm™ VanR Assay4416654416652016-05-19
00382904433802BD MAX™ Enteric Parasite Panel (US/CAN)4433804433802016-05-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B708ABFVR020XCELLAPEX BIOLOGIX , LLCJJH2026-03-26
06955792702844Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702851Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702868Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
04053228040576EZ2 Connect MDxQIAGEN GmbHJJH2026-03-03
00849811081835Maxwell® CSC Rapid ccfDNA KitPROMEGA CORPORATIONJJH2026-02-16
00849811083778Maxwell® CSC XtractAll FFPE DNA/RNA KitPROMEGA CORPORATIONJJH2026-02-16
04719882810046IntelliPrep TRIO 240 Sample Preparation SystemPlexBio Co., Ltd.JJH2026-01-28
04719882810237IntelliPrep Blood Genomic DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810268IntelliPrep FFPE DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810282IntelliPrep FFPE RNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719882810299IntelliPrep cfDNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719880121397TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121403TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121441TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121458TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122097TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122103TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122158TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122165TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122370TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122387TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122431TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122660TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122707TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122882TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122899TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07