FDA.reportPublic FDA data

NX Universal NA Kit A NUE041

Primary DI
08800174503008
Brand
NX Universal NA Kit A NUE041
Company
GENOLUTION. INC.
Model
NUE041
Published
2023-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
08800174503008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800174503008088001745030088800174503008

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 Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688418843
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800174502988NX Universal NA Kit A NUE961NUE9612023-11-08
08800174502995NX Universal NA Kit A NUE321NUE3212023-11-08
08800174503015NX Universal DNA Kit B NUE962NUE9622023-11-08
08800174503022NX Universal DNA Kit B NUE322NUE3222023-11-08
08800174503039NX Universal DNA Kit B NUE042NUE0422023-11-08
08800174503046NX Universal DNA Kit C NUE963 NUE9632023-11-08
08800174503053NX Universal DNA Kit C NUE323NUE3232023-11-08
08800174503060NX Universal DNA Kit C NUE043NUE0432023-11-08
08800174503084NX Genomic DNA Kit A NGD321NGD3212023-11-08
08800174503091NX Genomic DNA Kit A NGD041NGD0412023-11-08
08800174503107NX Genomic DNA Kit B NGD962NGD9622023-11-08
08800174503114NX Genomic DNA Kit B NGD322NGD3222023-11-08
08800174503121NX Genomic DNA Kit B NGD042NGD0422023-11-08
08800174502933NX-Duo cfDNA Kit A DCF242DCF2422023-11-07
08800174502940NX-Duo cfDNA Kit A DCF244DCF2442023-11-07
08800174503282NX-Duo Universal DNA Kit A DUE961DUE9612023-11-07
08800174503299NX-Duo Universal DNA Kit A DUE481DUE4812023-11-07
08800174503305NX-Duo Universal DNA Kit A DUE241DUE2412023-11-07
08800174503312NX-Duo Universal DNA Kit B DUE962DUE9622023-11-07
08800174503329NX-Duo Universal DNA Kit B DUE482DUE4822023-11-07

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