PAXgene® Blood RNA Tube

Primary DI
54053727621653
Brand
PAXgene® Blood RNA Tube
Company
PreAnalytiX GmbH
Model
762165
Catalog number
762165
Device description
PAXgene® Blood RNA Tube
Published
2016-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
54053727621653PrimaryGS10
04053727621658Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5405372762165354053727621653
04053727621658040537276216584053727621658

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, nucleic acid stabilizerA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and a nucleic acid [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] stabilizer. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480915029
Device count
100
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053727611659PAXgene® Blood DNA Tube7611657611652016-07-28
04053727621658PAXgene® Blood RNA Tube7621657621652016-10-25
04053727000149PAXgene® Blood RNA KitVersion 27621642025-02-26
54053727611654PAXgene® Blood DNA Tube7611657611652016-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053727000149PAXgene® Blood RNA KitPreAnalytiX GmbHNTW2025-02-26
04053727621658PAXgene® Blood RNA TubePreAnalytiX GmbHNTW2016-10-25