Home GUDID 10850046056007 Platelet PGDprime Test
Primary DI 10850046056007
Brand Platelet PGDprime Test
Company Verax Biomedical Incorporated
Model T.00001186E
Device description Platelet PGDprime Test single device pouch
Published 2023-04-17
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MZC System, Detection, Bacterial, For Platelet Transfusion Products
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MZC System, Detection, Bacterial, For Platelet Transfusion Products Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850046056106 Package GS1 100 In Commercial Distribution 10850046056007 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10850046056106 10850046056106 10850046056007 10850046056007
GMDN Terms# Term, Definition table Term Definition Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical A 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 102312712 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10850046056069 Platelet PGDprime Sample Pipettes P01230 2023-04-19 10850046056076 Platelet PGDprime Processing Tubes P01462 2023-04-19 10850046056083 Platelet PGDprime Transfer Pipettes P01229 2023-04-19 10850046056090 Platelet PGDprime Processing Tubes P01463 2023-04-19 10850046056021 Platelet PGDprime Reagent 1B P01413 2023-04-19 10850046056045 Platelet PGDprime Positive Control P01412 2023-04-19 10850046056250 Platelet PGDprime Sample Pipettes P01230 2023-04-19 10850046056243 Platelet PGDprime Transfer Pipettes P01229 2023-04-19 10850046056236 Platelet PGDprime Processing Tubes P01463 2023-04-19 10850046056113 Platelet PGDprime Test, 20 devices plus disposables PRM20T PRM20T 2023-04-19 10850046056120 Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer Pipettes PRM100D PRM100D 2023-04-19 10850046056137 Platelet PGDprime Reagents, 100 Test PRM100R PRM100R 2023-04-19 10850046056144 Platelet PGDprime Reagents, 20 Test PRM20R PRM20R 2023-04-19 10850046056151 Platelet PGDprime Controls PRM30C PRM30C 2023-04-19 10850046056014 Platelet PGDprime Reagent 1A P01111 2023-04-13 10850046056038 Platelet PGDprime Reagent 2 P01214 2023-04-13 10850046056052 Platelet PGDprime Negative Control P01113 2023-04-13
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00382904420536 BD BACTEC™ Platelet Aerobic/F Culture Vials BECTON, DICKINSON AND COMPANY MZC 2023-10-05 00382904420543 BD BACTEC™ Platelet Anaerobic/F Culture Vials BECTON, DICKINSON AND COMPANY MZC 2023-10-05 30382904420537 BD BACTEC™ Platelet Aerobic/F Culture Vials BECTON, DICKINSON AND COMPANY MZC 2023-10-05 30382904420544 BD BACTEC™ Platelet Anaerobic/F Culture Vials BECTON, DICKINSON AND COMPANY MZC 2023-10-05 10850046056069 Platelet PGDprime Sample Pipettes Verax Biomedical Incorporated MZC 2023-04-19 10850046056076 Platelet PGDprime Processing Tubes Verax Biomedical Incorporated MZC 2023-04-19 10850046056083 Platelet PGDprime Transfer Pipettes Verax Biomedical Incorporated MZC 2023-04-19 10850046056090 Platelet PGDprime Processing Tubes Verax Biomedical Incorporated MZC 2023-04-19 10850046056021 Platelet PGDprime Reagent 1B Verax Biomedical Incorporated MZC 2023-04-19 10850046056250 Platelet PGDprime Sample Pipettes Verax Biomedical Incorporated MZC 2023-04-19 10850046056243 Platelet PGDprime Transfer Pipettes Verax Biomedical Incorporated MZC 2023-04-19 10850046056236 Platelet PGDprime Processing Tubes Verax Biomedical Incorporated MZC 2023-04-19 10850046056113 Platelet PGDprime Test, 20 devices plus disposables Verax Biomedical Incorporated MZC 2023-04-19 10850046056120 Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer Pipettes Verax Biomedical Incorporated MZC 2023-04-19 10850046056137 Platelet PGDprime Reagents, 100 Test Verax Biomedical Incorporated MZC 2023-04-19 10850046056144 Platelet PGDprime Reagents, 20 Test Verax Biomedical Incorporated MZC 2023-04-19 10850046056014 Platelet PGDprime Reagent 1A Verax Biomedical Incorporated MZC 2023-04-13 10850046056038 Platelet PGDprime Reagent 2 Verax Biomedical Incorporated MZC 2023-04-13 03573026612047 BACT/ALERT® BPA BIOMERIEUX , INC. MZC 2020-06-26 03573026614157 BACT/ALERT® BPN BIOMERIEUX , INC. MZC 2020-06-26 03573026614140 BACT/ALERT® BIOMERIEUX , INC. MZC 2020-06-26 03573026611323 BACT/ALERT® BIOMERIEUX , INC. MZC 2020-06-26 03573026595975 BACT/ALERT® BPA BIOMERIEUX , INC. MZC 2020-04-27 03573026595999 BACT/ALERT® BPN BIOMERIEUX , INC. MZC 2020-04-27 03573026126742 BACT/ALERT® BPA BIOMERIEUX , INC. MZC 2020-04-27 03573026126735 BACT/ALERT® BPN BIOMERIEUX , INC. MZC 2020-04-27 20887691306376 Haemonetics HAEMONETICS CORPORATION MZC 2017-03-20 30887691306373 Haemonetics HAEMONETICS CORPORATION MZC 2017-03-20
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