FDA.reportPublic FDA data

HemosIL AcuStar HIT-IgG (PF4-H)

Primary DI
08426951126545
Brand
HemosIL AcuStar HIT-IgG (PF4-H)
Company
INSTRUMENTATION LABORATORY COMPANY
Model
0009800127
Catalog number
00009800127
Device description
1. HIT- IgG(PF4-H)Cartridges for 25 determinations (Cat No 0009800128) 2. HIT-IgG (PF4-H) Calibaratior 1 (Cat No 0009800129)3. HIT-IgG (PF4-H) Calibaratior 2 (Cat No 0009800130)
Published
2018-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170854000HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO2017-09-08LCO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426951126545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426951126545084269511265458426951126545

GMDN Terms#

Term, Definition table
TermDefinition
Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of platelet factor 4 in a clinical specimen using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify001. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks 2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
Special Storage Condition, Specify001. HIT- IgG(PF4-H) Cartridges - Stability after opening on-board for 12 weeks2. HIT-IgG (PF4-H) Calibrators - Stability after opening on-board is 4 hours
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-678-0710techsupport@werfen.com
1-800-678-0710techsupport.na@werfen.com

Regulatory Flags#

DUNS number
557223252
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08426950071068HemosIL Normal Control ASSAYED00020003110000200031102016-09-23
08426950088646GEM Check Coag Control-Abnormal for ACT-LR06260060200062600602002016-09-23
08426950088653GEM Check Coag Control-Abnormal for ACT06260060300062600603002016-09-23
08426950452683GEM Check Coag Control-Normal for Citrate PT06260061100062600611002016-09-23
08426950452713GEM Check Coag Control-Abnormal for Citrate PT06260061400062600614002016-09-23
08426950452744GEM Check Coag Control-Normal for ACT06260060500062600605002016-09-23
08426950452751GEM Check Coag Control-Normal for ACT-LR06260060600062600606002016-09-23
08426950573401HemosIL Routine Control Level 300020005800000200058002016-09-23
08426950660668HemosIL Abnormal Control 200020014000000200140002016-09-23
08426950078982HemosIL Low Abnormal Control ASSAYED00020003210000200032102016-09-23
08426950078999HemosIL High Abnormal Control ASSAYED00020003310000200033102016-09-23
08426950087595HemosIL Calibration Plasma00020003700000200037002016-09-23
08426950088639GEM Check Coag Control-Abnormal for APTT06260060100062600601002016-09-23
08426950088912Coatest APCR Control Plasma Level 182 2650 6382 2650 632016-09-23
08426950088929Coatest APCR Control Plasma Level 282 2668 6382 2668 632016-09-23
08426950442189HemosIL Special Test Control Level 200020012000000200120002016-09-23
08426950452690GEM Check Coag Control-Normal for APTT06260061600062600616002016-09-23
08426950452706GEM Check Coag Control-Abnormal for PT06260061700062600617002016-09-23
08426950452737GEM Check Coag Control-Normal for PT06260060400062600604002016-09-23
08426950453062HemosIL Special Test Control Level 100020011000000200110002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195226001204HemosIL CL HIT-IgG (PF4-H)INSTRUMENTATION LABORATORY COMPANYLCO2025-10-30
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
10888234500438Positive Serum ControlIMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-08
10888234500025PF4 Enhanced® IMMUCOR GTI DIAGNOSTICS, INC.LCO2016-07-01