Home GUDID M52533480 SPIFE ALP Separation Enhancer
Primary DI M52533480
Brand SPIFE ALP Separation Enhancer
Company HELENA LABORATORIES CORPORATION
Model 3348
Published 2016-09-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name CIN ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M52533480 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Alkaline phosphatase (ALP) isoenzyme IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of one or multiple alkaline phosphatase (ALP) isoenzymes in a clinical specimen.
Regulatory Flags# DUNS number 079396131 Device count 1 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 M52551830 AB-Trol 3 Coagulation Control 5183 2016-08-18 M52551850 Coagulation S.A.R.P (Specialty Assayed Reference Plasma) 5185 2016-09-07 M52551860 NORM-TROL 1 Coagulation Control 5186 2016-09-07 M52551870 AB-TROL 2 Coagulation Control 5187 2016-09-07 M52553010 Coagulation S.A.C.-1 (Specialty Assay Control) 5301 2016-09-07 M52553020 Coagulation S.A.C.-2 (Specialty Assay Control) 5302 2016-09-07 M52536110 H-Pette without Blade (1000 pieces) 3611 2017-05-26 M52536120 H-Pette with Blade (1000 pieces) 3612 2017-05-26 M52536130 H-Pette Remover 3613 2017-03-17 M52536150 H-Pette II (No Blade, Metal Canula) (1000 pieces) 3615 2017-05-26 M52594230 IFE Free Lambda Light Chain Antiserum 9423 2024-09-27 M5255527370 SPIFE Nexus IFE-6 Antisera Kit 552737 2024-09-27 M5255527440 SPIFE Nexus IFE-9/15 Antisera Kit 552744 2024-09-27 M52594190 IFE IgD Antiserum 9419 2024-09-27 M52594200 IFE IgE Antiserum 9420 2024-09-27 M52594220 IFE Free Kappa Light Chain Antiserum 9422 2024-09-27 M52520050000 ProtoFluor Z (110V) 2005000 2017-03-17 M52520050020 ProtoFluor Z (110V) 2005002 2017-03-17 M52520060000 ProtoFluor Z (220V) 2006000 2017-03-17 M52518360 V8 Urine Preparation Buffer 1836 2023-09-08
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05060169695801 IDS-iSYS Ostase® BAP IMMUNODIAGNOSTIC SYSTEMS LIMITED CIN 2021-03-08 30014613333920 MicroVue QUIDEL CORPORATION CIN 2016-09-15 15099590232313 Access Ostase Beckman Coulter, Inc. CIN 2016-09-09 M52530580 TITAN GEL Alkaline Phosphatase Kit HELENA LABORATORIES CORPORATION CIN 2016-09-07 M52551020 Alkaline Phosphatase Indolyl Blue Reagent Kit HELENA LABORATORIES CORPORATION CIN 2016-09-07 M5255510310 TITAN GEL Alkaline Phosphatase Reagent Kit HELENA LABORATORIES CORPORATION CIN 2016-09-07 M5255520550 SPIFE Alkaline Phosphatase Reagent Kit HELENA LABORATORIES CORPORATION CIN 2016-09-07 M5255523950 SPIFE Alkaline Phosphatase-20,40 Gel Kit HELENA LABORATORIES CORPORATION CIN 2016-09-07 M5255526040 SPIFE Alkaline Phosphatase Gel Kit HELENA LABORATORIES CORPORATION CIN 2016-09-07 06438115000082 UniQ® PINP RIA Aidian Oy CIN 2016-04-13 05060169690059 Ostase®+ BAP EIA IMMUNODIAGNOSTIC SYSTEMS LIMITED CIN 2016-04-01
helena.com