Home GUDID M5255526510 SPIFE A1AT Kit
Primary DI M5255526510
Brand SPIFE A1AT Kit
Company HELENA LABORATORIES CORPORATION
Model 552651
Published 2026-06-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name OBZ Alpha-1-Antitrypsin Kit, Qualitative Phenotype
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OBZ Alpha-1-Antitrypsin Kit, Qualitative Phenotype Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M5255526510 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Alpha-1-antitrypsin (protease inhibitor) IVD, kit, electrophoresis A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-1-antitrypsin (protease inhibitor) in a clinical specimen, using an electrophoresis method. Alpha-1-antitrypsin deficiency is typically associated with liver cirrhosis and pulmonary emphysema.
Regulatory Flags# DUNS number 079396131 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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
helena.com