FDA.reportPublic FDA data

Positive Serum Control

Primary DI
10888234500438
Brand
Positive Serum Control
Company
IMMUCOR GTI DIAGNOSTICS, INC.
Model
403625
Catalog number
403625
Device description
For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)
Published
2016-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCOPlatelet Factor 4 Radioimmunoassay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCOPlatelet Factor 4 RadioimmunoassayHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053559000PF4 ENHANCED SOLID PHASE ELISAGenetic Testing Institute2006-01-20LCO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234500438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823450043810888234500438

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
855-466-8267waukeshatechsupport@immucor.co
855-466-8267waukeshatechsupport@immucor.com
855-466-8267info@immucor.com

Regulatory Flags#

DUNS number
606034197
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888234500858MatchX8886288886282025-09-30
10888234500827Dilution Solution628515UDI628515UDI2020-05-20
10888234500841LIFECODES LifeScreen XP6282206282202023-07-11
10888234400332LIFECODES LSA Class I 265100IVD265100IVD2022-04-06
10888234400349LIFECODES LSA Class II 265200IVD265200IVD2022-04-06
10888234500810LIFECODES MATCH IT! Antibody Software8886278886272022-02-18
10888234500803LIFECODES MATCH IT!™ DNA Software v1.38886238886232020-02-26
10888234400011LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex6289136289132016-09-15
10888234400035LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex6289176289172016-09-15
10888234400059LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex6289216289212016-09-15
10888234400073LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex6289256289252016-09-15
10888234400080LIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use with Luminex6289276289272016-09-15
10888234400134LIFECODES TAQ Polymerase6280756280752016-09-15
10888234400295LIFECODES Class I ID Typing Kit for use with Luminex6282006282002016-09-15
10888234400301LIFECODES Class II IDv2 for use with Luminex6282236282232016-09-15
10888234400318LIFECODES LifeScreen Deluxe6282156282152016-09-15
10888234400462LIFECODES HLA-DQA1/B1 SSO Typing Kit for use with Luminex6289306289302016-09-15
10888234400479LIFECODES HLA-DPA1/B1 SSO Typing Kit for use with Luminex6289366289362016-09-15
10888234400509Conjugate Concentrate6282126282122016-09-15
10888234400516LIFECODES Wash Buffer6282116282112016-09-15

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
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
10888234500025PF4 Enhanced® IMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-01