FDA.reportPublic FDA data

Platelet PGDprime Processing Tubes

Primary DI
10850046056090
Brand
Platelet PGDprime Processing Tubes
Company
Verax Biomedical Incorporated
Model
P01463
Device description
Platelet PGDprime Processing Tubes are required for processing the platelet sample prior to testing with the Platelet PGDprime Test Device.
Published
2023-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZCSystem, Detection, Bacterial, For Platelet Transfusion Products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZCSystem, Detection, Bacterial, For Platelet Transfusion ProductsMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850046056090PrimaryGS10
10850046056236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085004605609010850046056090
1085004605623610850046056236

GMDN Terms#

Term, Definition table
TermDefinition
Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of the highly conserved bacterial antigens lipoteichoic acid (LTA) and lipopolysaccharide (LPS) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect gram-negative or gram-positive bacterial contamination of blood products (e.g., platelets). It is not intended to be used for self-testing.

Contacts#

Phone, Email table
PhoneEmail
866-948-3729vts@veraxbiomedical.com

Regulatory Flags#

DUNS number
102312712
Device count
20
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850046056069Platelet PGDprime Sample PipettesP012302023-04-19
10850046056076Platelet PGDprime Processing TubesP014622023-04-19
10850046056083Platelet PGDprime Transfer PipettesP012292023-04-19
10850046056021Platelet PGDprime Reagent 1BP014132023-04-19
10850046056045Platelet PGDprime Positive ControlP014122023-04-19
10850046056250Platelet PGDprime Sample PipettesP012302023-04-19
10850046056243Platelet PGDprime Transfer PipettesP012292023-04-19
10850046056236Platelet PGDprime Processing TubesP014632023-04-19
10850046056113Platelet PGDprime Test, 20 devices plus disposablesPRM20TPRM20T2023-04-19
10850046056120Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer PipettesPRM100DPRM100D2023-04-19
10850046056137Platelet PGDprime Reagents, 100 TestPRM100RPRM100R2023-04-19
10850046056144Platelet PGDprime Reagents, 20 TestPRM20RPRM20R2023-04-19
10850046056151Platelet PGDprime ControlsPRM30CPRM30C2023-04-19
10850046056007Platelet PGDprime TestT.00001186E2023-04-17
10850046056014Platelet PGDprime Reagent 1AP011112023-04-13
10850046056038Platelet PGDprime Reagent 2P012142023-04-13
10850046056052Platelet PGDprime Negative ControlP011132023-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382904420536BD BACTEC™ Platelet Aerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
00382904420543BD BACTEC™ Platelet Anaerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
30382904420537BD BACTEC™ Platelet Aerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
30382904420544BD BACTEC™ Platelet Anaerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
10850046056069Platelet PGDprime Sample PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056076Platelet PGDprime Processing TubesVerax Biomedical IncorporatedMZC2023-04-19
10850046056083Platelet PGDprime Transfer PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056021Platelet PGDprime Reagent 1BVerax Biomedical IncorporatedMZC2023-04-19
10850046056250Platelet PGDprime Sample PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056243Platelet PGDprime Transfer PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056236Platelet PGDprime Processing TubesVerax Biomedical IncorporatedMZC2023-04-19
10850046056113Platelet PGDprime Test, 20 devices plus disposablesVerax Biomedical IncorporatedMZC2023-04-19
10850046056120Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056137Platelet PGDprime Reagents, 100 TestVerax Biomedical IncorporatedMZC2023-04-19
10850046056144Platelet PGDprime Reagents, 20 TestVerax Biomedical IncorporatedMZC2023-04-19
10850046056007Platelet PGDprime TestVerax Biomedical IncorporatedMZC2023-04-17
10850046056014Platelet PGDprime Reagent 1AVerax Biomedical IncorporatedMZC2023-04-13
10850046056038Platelet PGDprime Reagent 2Verax Biomedical IncorporatedMZC2023-04-13
03573026612047BACT/ALERT® BPABIOMERIEUX , INC.MZC2020-06-26
03573026614157BACT/ALERT® BPNBIOMERIEUX , INC.MZC2020-06-26
03573026614140BACT/ALERT®BIOMERIEUX , INC.MZC2020-06-26
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03573026595975BACT/ALERT® BPABIOMERIEUX , INC.MZC2020-04-27
03573026595999BACT/ALERT® BPNBIOMERIEUX , INC.MZC2020-04-27
03573026126742BACT/ALERT® BPABIOMERIEUX , INC.MZC2020-04-27
03573026126735BACT/ALERT® BPNBIOMERIEUX , INC.MZC2020-04-27
20887691306376HaemoneticsHAEMONETICS CORPORATIONMZC2017-03-20
30887691306373HaemoneticsHAEMONETICS CORPORATIONMZC2017-03-20