FDA.reportPublic FDA data

Platelet PGDprime Controls

Primary DI
10850046056151
Brand
Platelet PGDprime Controls
Company
Verax Biomedical Incorporated
Model
PRM30C
Catalog number
PRM30C
Device description
Platelet PGDprime Positive and Negative Controls for quality control testing of the Platelet PGDprime Test System.
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
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850046056151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085004605615110850046056151

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
102312712
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration 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
10850046056090Platelet PGDprime Processing TubesP014632023-04-19
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
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
00850010224459CareSuperb COVID-19/Flu A&B Antigen Combo External ControlAccess Bio Inc.JJY2026-06-08
05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442848Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442855Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30
00850028489109TriVerity Mini Verification PanelInflammatix, Inc.JJY2026-04-30
00850011135747VALIDATELgc Clinical Diagnostics, Inc.JJY2026-04-24
00850075957330KOVA-Trol II Low AbnormalLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957378KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957385KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value AssignmentLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08