PAXgene® Blood RNA Kit

Primary DI
04053727000149
Brand
PAXgene® Blood RNA Kit
Company
PreAnalytiX GmbH
Model
Version 2
Catalog number
762164
Device description
The PAXgene® Blood RNA Kit isolates and purifies RNA from blood collected in a PAXgene® Blood RNA Tube.
Published
2025-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NTWSystem, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTWSystem, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic TestImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082150000MODIFICATION TO PAXGENE BLOOD RNA SYSTEMPreanalytix GmbH2009-02-04NTW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053727000149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053727000149040537270001494053727000149

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 Celsius8 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480915029
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053727611659PAXgene® Blood DNA Tube7611657611652016-07-28
04053727621658PAXgene® Blood RNA Tube7621657621652016-10-25
54053727621653PAXgene® Blood RNA Tube7621657621652016-10-25
54053727611654PAXgene® Blood DNA Tube7611657611652016-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053727621658PAXgene® Blood RNA TubePreAnalytiX GmbHNTW2016-10-25
54053727621653PAXgene® Blood RNA TubePreAnalytiX GmbHNTW2016-10-25