FDA.reportPublic FDA data

PIFA PLUSS® PF4 Rapid Assay

Primary DI
00708872000042
Brand
PIFA PLUSS® PF4 Rapid Assay
Company
AKERS BIOSCIENCES, INC.
Model
4001101
Catalog number
4001101
Device description
A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to platelet factor 4-heparin complex in a clinical specimen within a short period, relative to standard laboratory testing procedures, using PIFA PLUSS® PF4 Rapid Assay.
Published
2018-06-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCOPlatelet Factor 4 Radioimmunoassay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCOPlatelet Factor 4 RadioimmunoassayHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00708872615124PreviousGS10
00708872000042PrimaryGS10
01708872000042Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00708872615124007088726151247088726151240708872615124
00708872000042007088720000427088720000420708872000042
01708872000042017088720000421708872000042

GMDN Terms#

Term, Definition table
TermDefinition
Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total antibodies to platelet factor 4-heparin complex in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in a laboratory or in point-of-care analyses to aid in the investigation/diagnosis of heparin induced thrombocytopenia (HIT). 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

Contacts#

Phone, Email table
PhoneEmail
8568488698mrodriguez@akers.com

Regulatory Flags#

DUNS number
611245549
Device count
6
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00708872615123 PIFA® Heparin/PF4 Rapid Assay403602540360252016-09-24
00708872000004Heparin/PF4 Antibody Serum Panel403602740360272018-03-05
00708872000011Heparin/PF4 Antibody Serum Panel403602840360282018-03-05
00708872615124PIFA PLUSS® PF4 Rapid Assay400110140011012018-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195226001204HemosIL CL HIT-IgG (PF4-H)INSTRUMENTATION LABORATORY COMPANYLCO2025-10-30
08426951126545HemosIL AcuStar HIT-IgG (PF4-H)INSTRUMENTATION LABORATORY COMPANYLCO2018-07-12
00708872615124PIFA PLUSS® PF4 Rapid AssayAKERS BIOSCIENCES, INC.LCO2018-06-04
00708872615123 PIFA® Heparin/PF4 Rapid AssayAKERS BIOSCIENCES, INC.LCO2016-09-24
08426950975380HemosIL HIT-Ab(PF4-H)INSTRUMENTATION LABORATORY COMPANYLCO2016-09-23
03607450009514Asserachrom® PF4DIAGNOSTICA STAGOLCO2016-09-15
03607450006155Asserachrom® HPIADIAGNOSTICA STAGOLCO2016-09-15
03663537018763ZYMUTEST HIA IgGHYPHEN BIOMEDLCO2016-08-25
03663537018770ZYMUTEST HIA IgGAMHYPHEN BIOMEDLCO2016-08-25
03663537046803ZYMUTEST HIA MonoStrip IgGHYPHEN BIOMEDLCO2016-08-25
03663537046810ZYMUTEST HIA MonoStrip IgGAMHYPHEN BIOMEDLCO2016-08-25
10888234500032PF4 Enhanced®IMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-08
10888234500049PF4 IgGIMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-08
10888234500056PF4 IgGIMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-08
10888234500353Specimen DiluentIMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-08
10888234500384Anti-Human IgG ConjugateIMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-08
10888234500391Anti-Human IgG/A/M ConjugateIMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-08
10888234500414Negative Serum ControlIMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-08
10888234500421PF4 Concentrated Wash (10x)IMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-08
10888234500438Positive Serum ControlIMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-08
10888234500025PF4 Enhanced® IMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-01