PAXgene® Blood DNA Tube

Primary DI
04053727611659
Brand
PAXgene® Blood DNA Tube
Company
PreAnalytiX GmbH
Model
761165
Catalog number
761165
Device description
PAX DNA IVD BLOOD COLLECTION TUBE
Published
2016-07-28
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
PJEBlood/plasma collection device for DNA testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJEBlood/Plasma Collection Device For Dna TestingClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231469000PAXgene® Blood DNA TubePreanalytix GmbH2023-06-21PJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34053727611650PackageGS1100In Commercial Distribution
54053727611654PackageGS11000In Commercial Distribution
04053727611659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3405372761165034053727611650
5405372761165454053727611654
04053727611659040537276116594053727611659

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizerA glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant agent [e.g., tripotassium ethylene diamine tetraacetic acid (K3EDTA)], and a nucleic acid (DNA/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
Length75Millimeter
Total Volume2.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Room Temperature
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
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
04053727621658PAXgene® Blood RNA Tube7621657621652016-10-25
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
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29120017571876VacuetteGreiner Bio-One GmbHPJE2017-04-20
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