Home GUDID M5255516740
Blade Applicator Kit, 20 Sample
Primary DI M5255516740
Brand Blade Applicator Kit, 20 Sample
Company HELENA LABORATORIES CORPORATION
Model 551674
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 JHY COLORIMETRIC METHOD, CPK OR ISOENZYMES
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JHY Colorimetric Method, Cpk Or Isoenzymes Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M5255516740 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Creatine kinase (CK) multiple 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 qualitative and/or quantitative detection of one or multiple creatine kinase (CK) isoenzymes in a clinical specimen.
Regulatory Flags# DUNS number 079396131 Device count 1 Lot or batch 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 00816870020655 CK-MB AccuBind ELISA Test System - 96 Wells MONOBIND, INC. JHY 2019-02-11 00816870020662 CK-MB AccuBind ELISA Test System - 192 Wells MONOBIND, INC. JHY 2019-02-11 00816870022338 Monobind AccuLite CKMB CLIA Kit - 96 Wells MONOBIND, INC. JHY 2019-02-11 00816870022345 CK-MB AccuLite CLIA Test System - 192 Wells MONOBIND, INC. JHY 2019-02-11 04015630939978 Elecsys CK-MB Roche Diagnostics GmbH JHY 2017-04-21 04015630939534 CalSet CK-MB Roche Diagnostics GmbH JHY 2017-04-17 M525552612 SPIFE CK-20,40 Gel Kit HELENA LABORATORIES CORPORATION JHY 2017-02-10 15099590011468 AU Beckman Coulter, Inc. JHY 2016-09-24 00842768013829 Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge Siemens Healthcare Diagnostics Inc. JHY 2016-09-24 00842768013898 Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge Siemens Healthcare Diagnostics Inc. JHY 2016-09-24 00842768015328 Dimension Vista® Flex® reagent cartridge MMB Siemens Healthcare Diagnostics Inc. JHY 2016-09-24 04015630928729 Elecsys CKMB STAT CalSet Roche Diagnostics GmbH JHY 2016-09-20 04015630934638 Elecsys CKMB STAT Immunoassay Roche Diagnostics GmbH JHY 2016-09-20 04015630934621 Elecsys CKMB Immunoassay Roche Diagnostics GmbH JHY 2016-09-20 M5255517650 Blade Applicator Kit, 20 Sample HELENA LABORATORIES CORPORATION JHY 2016-09-07 M5255520150 SPIFE CK-20,40 Gel Kit HELENA LABORATORIES CORPORATION JHY 2016-09-07 M5255520280 SPIFE CK Reagent Kit HELENA LABORATORIES CORPORATION JHY 2016-09-07 M5255523960 QuickGel CK Vis Gel Kit HELENA LABORATORIES CORPORATION JHY 2016-09-07 M5255525890 Blade Applicator Kit, 20 Sample HELENA LABORATORIES CORPORATION JHY 2016-09-07 M5255525900 Blade Applicator Kit, 20 Sample HELENA LABORATORIES CORPORATION JHY 2016-09-07