FDA.reportPublic FDA data

Abbott mSample Preparation System DNA

Primary DI
00849811004452
Brand
Abbott mSample Preparation System DNA
Company
PROMEGA CORPORATION
Model
06K12-24
Catalog number
06K12-24
Device description
Abbott mSample Preparation System DNA is a nucleic acid extraction system used for laboratory isolation of DNA from biological samples.
Published
2017-08-25
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
JJHClinical Sample Concentrator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849811004452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849811004452008498110044528498110044520849811004452

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 Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-7042customerservice@abbottmolecular.com

Regulatory Flags#

DUNS number
089855696
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849811081835Maxwell® CSC Rapid ccfDNA KitAS1580AS15802026-02-16
00849811083457OncoMate® MSI Dx Analysis SoftwareMD4160MD41602026-02-16
00849811083778Maxwell® CSC XtractAll FFPE DNA/RNA KitAS1560AS15602026-02-16
00849811089114OncoMate® MSI Dx Assay InstallerMD4130MD41302026-02-16
00849811031717OncoMate MSI Dx Analysis SystemMD2140MD21402021-09-30
00849811050619OncoMate 5C Matrix StandardMD4850MD48502021-09-30
00849811066115Maxwell® CSC Genomic DNA KitAS1850AS18502023-06-12
00849811060960Maxwell® CSC Viral Total Nucleic Acid Purification Kit AS1780AS17802022-02-01
00849811064647Maxwell® CSC Whole Blood DNA KitAS1820AS18202022-02-01
00849811069062Maxwell® CSC Pathogen Total Nucleic Acid Kit AS1860AS18602023-06-12
00849811051340Maxwell® CSC InstrumentAS6000AS60002022-02-01
00849811060991Maxwell® CSC 48 InstrumentAS8000AS80002022-02-01
00849811075902QuantiFluor® Dx dsDNA SystemE5900E59002023-08-15
00849811051739Maxwell® CSC RNA Blood KitAS1410AS14102022-02-01
00849811051746Maxwell® CSC RNA FFPE KitAS1360AS13602022-02-01
00849811051753Maxwell® CSC DNA FFPE KitAS1350AS13502022-02-01
00849811051777Maxwell® CSC Blood DNA KitAS1321AS13212022-02-01
00849811056857OncoMate MSI Dx Interpretive SoftwareMD4140MD41402021-10-08
00849811056864OncoMate MSI Dx Assay InstallerMD4150MD41502021-10-08
00849811004445Abbott mSample Preparation System04J70-2404J70-242017-08-25

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