Home GUDID M52553410 Beta-Thal HbA2 Quik Column Kit
Primary DI M52553410
Brand Beta-Thal HbA2 Quik Column Kit
Company HELENA LABORATORIES CORPORATION
Model 5341
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 JPD HEMOGLOBIN A2 QUANTITATION
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JPD Hemoglobin A2 Quantitation Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M52553410 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Inherited haemoglobinopathy 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 to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia.
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 04560189283114 TSKgel G7 β-Thal. HSi TOSOH CORPORATION JPD 2016-09-24 04560189283503 G7 Beta-Thalassemia Elution Buffer Kit TOSOH CORPORATION JPD 2016-09-24 04560189283664 Hemoglobin F&A2 Calibrator TOSOH CORPORATION JPD 2016-09-24 04560189283671 Hemoglobin F&A2 Control Set TOSOH CORPORATION JPD 2016-09-24 00847817000096 D-10 Dual BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817000447 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817000805 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817003301 D-10 BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817003448 D-10 Dual BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817003455 D-10 Dual BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817003462 D-10 BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817003509 D-10 Dual BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817008610 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817008634 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817009204 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817009914 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817010606 Whole Blood Primer BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817012273 VARIANT II / VARIANT II TURBO BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817012303 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 M52553340 Sickle-Thal Quik Column Kit HELENA LABORATORIES CORPORATION JPD 2016-09-07
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