FDA.reportPublic FDA data

PIFA PLUSS® PF4 Rapid Assay

Primary DI
00708872615124
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00708872000042PrimaryGS10
00708872615124PrimaryGS10
01708872000042Unit of UseGS10
01708872615124Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00708872000042007088720000427088720000420708872000042
00708872615124007088726151247088726151240708872615124
01708872000042017088720000421708872000042
01708872615124017088726151241708872615124

GMDN Terms#

Term, Definition table
TermDefinition
Platelet factor 4-heparin complex total antibody IVD, kit, agglutination, rapidA 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 an agglutination method. This test is commonly used in a laboratory or in point-of-care analysis to aid in the investigation/diagnosis of heparin induced thrombocytopenia (HIT).

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
8568488698mrodriguez@akers.com

Regulatory Flags#

DUNS number
611245549
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00708872000042PIFA PLUSS® PF4 Rapid Assay400110140011012018-06-04
00708872615123 PIFA® Heparin/PF4 Rapid Assay403602540360252016-09-24
00708872000004Heparin/PF4 Antibody Serum Panel403602740360272018-03-05
00708872000011Heparin/PF4 Antibody Serum Panel403602840360282018-03-05

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
00708872000042PIFA 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