Home GUDID 00195226001204 HemosIL CL HIT-IgG (PF4-H)
Primary DI 00195226001204
Brand HemosIL CL HIT-IgG (PF4-H)
Company INSTRUMENTATION LABORATORY COMPANY
Model 0029706200
Catalog number 00029706200
Device description HemosIL CL HIT-IgG (PF4-H)CL HIT-IgG(PF4-H) Cartridge (Cat. No. 0029706210): 1CL HIT-IgG(PF4-H) Calibrator 1 (Cat. No. 0029706220): 1 x 1.2 mLCL HIT-IgG(PF4-H) Calibrator 2 (Cat. No. 0029706230): 1 x 1.2 mL
Published 2025-10-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LCO Platelet Factor 4 Radioimmunoassay
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LCO Platelet Factor 4 Radioimmunoassay Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00195226001204 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00195226001204 00195226001204 195226001204 0195226001204
GMDN Terms# Term, Definition table Term Definition 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 Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
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 DI Brand Model Catalog Published 08426950071068 HemosIL Normal Control ASSAYED 00020003110 00020003110 2016-09-23 08426950088646 GEM Check Coag Control-Abnormal for ACT-LR 06260060200 06260060200 2016-09-23 08426950088653 GEM Check Coag Control-Abnormal for ACT 06260060300 06260060300 2016-09-23 08426950452683 GEM Check Coag Control-Normal for Citrate PT 06260061100 06260061100 2016-09-23 08426950452713 GEM Check Coag Control-Abnormal for Citrate PT 06260061400 06260061400 2016-09-23 08426950452744 GEM Check Coag Control-Normal for ACT 06260060500 06260060500 2016-09-23 08426950452751 GEM Check Coag Control-Normal for ACT-LR 06260060600 06260060600 2016-09-23 08426950573401 HemosIL Routine Control Level 3 00020005800 00020005800 2016-09-23 08426950660668 HemosIL Abnormal Control 2 00020014000 00020014000 2016-09-23 08426950078982 HemosIL Low Abnormal Control ASSAYED 00020003210 00020003210 2016-09-23 08426950078999 HemosIL High Abnormal Control ASSAYED 00020003310 00020003310 2016-09-23 08426950087595 HemosIL Calibration Plasma 00020003700 00020003700 2016-09-23 08426950088639 GEM Check Coag Control-Abnormal for APTT 06260060100 06260060100 2016-09-23 08426950088912 Coatest APCR Control Plasma Level 1 82 2650 63 82 2650 63 2016-09-23 08426950088929 Coatest APCR Control Plasma Level 2 82 2668 63 82 2668 63 2016-09-23 08426950442189 HemosIL Special Test Control Level 2 00020012000 00020012000 2016-09-23 08426950452690 GEM Check Coag Control-Normal for APTT 06260061600 06260061600 2016-09-23 08426950452706 GEM Check Coag Control-Abnormal for PT 06260061700 06260061700 2016-09-23 08426950452737 GEM Check Coag Control-Normal for PT 06260060400 06260060400 2016-09-23 08426950453062 HemosIL Special Test Control Level 1 00020011000 00020011000 2016-09-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08426951126545 HemosIL AcuStar HIT-IgG (PF4-H) INSTRUMENTATION LABORATORY COMPANY LCO 2018-07-12 00708872000042 PIFA PLUSS® PF4 Rapid Assay AKERS BIOSCIENCES, INC. LCO 2018-06-04 00708872615124 PIFA PLUSS® PF4 Rapid Assay AKERS BIOSCIENCES, INC. LCO 2018-06-04 00708872615123 PIFA® Heparin/PF4 Rapid Assay AKERS BIOSCIENCES, INC. LCO 2016-09-24 08426950975380 HemosIL HIT-Ab(PF4-H) INSTRUMENTATION LABORATORY COMPANY LCO 2016-09-23 03607450009514 Asserachrom® PF4 DIAGNOSTICA STAGO LCO 2016-09-15 03607450006155 Asserachrom® HPIA DIAGNOSTICA STAGO LCO 2016-09-15 03663537018763 ZYMUTEST HIA IgG HYPHEN BIOMED LCO 2016-08-25 03663537018770 ZYMUTEST HIA IgGAM HYPHEN BIOMED LCO 2016-08-25 03663537046803 ZYMUTEST HIA MonoStrip IgG HYPHEN BIOMED LCO 2016-08-25 03663537046810 ZYMUTEST HIA MonoStrip IgGAM HYPHEN BIOMED LCO 2016-08-25 10888234500032 PF4 Enhanced® IMMUCOR GTI DIAGNOSTICS, INC. LCO 2016-07-08 10888234500049 PF4 IgG IMMUCOR GTI DIAGNOSTICS, INC. LCO 2016-07-08 10888234500056 PF4 IgG IMMUCOR GTI DIAGNOSTICS, INC. LCO 2016-07-08 10888234500353 Specimen Diluent IMMUCOR GTI DIAGNOSTICS, INC. LCO 2016-07-08 10888234500384 Anti-Human IgG Conjugate IMMUCOR GTI DIAGNOSTICS, INC. LCO 2016-07-08 10888234500391 Anti-Human IgG/A/M Conjugate IMMUCOR GTI DIAGNOSTICS, INC. LCO 2016-07-08 10888234500414 Negative Serum Control IMMUCOR GTI DIAGNOSTICS, INC. LCO 2016-07-08 10888234500421 PF4 Concentrated Wash (10x) IMMUCOR GTI DIAGNOSTICS, INC. LCO 2016-07-08 10888234500438 Positive Serum Control IMMUCOR GTI DIAGNOSTICS, INC. LCO 2016-07-08 10888234500025 PF4 Enhanced® IMMUCOR GTI DIAGNOSTICS, INC. LCO 2016-07-01
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