PAXgene® Blood RNA Tube

Primary DI
04053727621658
Brand
PAXgene® Blood RNA Tube
Company
PreAnalytiX GmbH
Model
762165
Catalog number
762165
Device description
TUBE RNA PLH 16X100 2.5 PLBLCE CLR
Published
2016-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
54053727621653PackageGS1100In Commercial Distribution
04053727621658PrimaryGS10

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 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length100Millimeter
Total Volume2.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00This way up
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480915029
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053727611659PAXgene® Blood DNA Tube7611657611652016-07-28
04053727000149PAXgene® Blood RNA KitVersion 27621642025-02-26
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
04053727000149PAXgene® Blood RNA KitPreAnalytiX GmbHNTW2025-02-26
54053727621653PAXgene® Blood RNA TubePreAnalytiX GmbHNTW2016-10-25