FDA.reportPublic FDA data

QuantiFluor® Dx dsDNA System

Primary DI
00849811075902
Brand
QuantiFluor® Dx dsDNA System
Company
PROMEGA CORPORATION
Model
E5900
Catalog number
E5900
Device description
The QuantiFluor® Dx dsDNA System is a fluorescent dye-based test intended to quantify double-stranded DNA (dsDNA) in a sample containing purified nucleic acid.
Published
2023-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PEGNucleic Acid Quantitation Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEGNucleic Acid Quantitation KitClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849811075902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849811075902008498110759028498110759020849811075902

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
608-839-7919techserv@promega.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
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
00849811004452Abbott mSample Preparation System DNA06K12-2406K12-242017-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974689624014TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624021TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624038TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624045TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624052TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624069TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624076TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624083TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624090TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624113TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624120TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624137TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624144TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624151TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624168TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624175TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624182TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624199TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624236TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624243TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624250TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624267TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624007TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-09-14
06974689624106TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-02-15