FDA.reportPublic FDA data

Asserachrom® HPIA

Primary DI
03607450006155
Brand
Asserachrom® HPIA
Company
DIAGNOSTICA STAGO
Model
00615
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K003767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003767000ASSERACHROM HPIA TEST KITDiagnostica Stago, Inc.2001-02-12LCO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607450006155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607450006155036074500061553607450006155

GMDN Terms#

Term, Definition table
TermDefinition
Platelet factor 4-heparin complex antibody IVD, kit, enzyme immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of antibodies to platelet factor 4-heparin complex in a clinical specimen, using an enzyme immunoassay method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262277122
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607450006766STA® - Coag Control N + ABN006762016-09-15
03607450006773STA® - Coag Control (N + ABN) PLUS006772016-09-15
03607450006780STA® - System Control N + P006782016-09-15
03607450005264STA® - Liatest® Control N + P005262016-09-15
13607450006756STA® - Unicalibrator006752016-09-15
13607450011392Pool Norm011392016-09-15
03607450005400FDP Plasma005402016-09-15
13607450005414FDP Plasma (Latex)005412016-09-15
13607450005513FDP Plasma (Buffer)005512016-09-15
13607450006749STA® - Fibrinogen 5006742016-09-15
03607450589894STA Compact Max® (with cap piercing option)589892016-09-15
03607450589900STA Compact Max®589902016-09-15
03607450590265STA R Max®590262018-10-30
03607450590272STA R Max® (with cap piercing option)590272018-10-30
13607450009757STA® - Desorb U009752020-09-24
03607450009736STA® - Cleaner Solution009732020-09-29
13607450003601STA® - Owren-Koller003602018-09-24
03607450000030STA Coag Expert®V8871112022-12-09
03607450000047Coag.One server licenseV8867652022-12-09
03607450867657Coag.One server licenseV7867652022-12-09

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
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