Colorimetric Method, Cpk Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1215
Recent MDR events
51 adverse event reports on file
- ELECSYS CK-MBMay 12, 2026MalfunctionRoche Diagnostics1823260-2026-01863
- ELECSYS CK-MBJun 6, 2023MalfunctionRoche Diagnostics1823260-2023-01879
- ELECSYS CK-MBMar 23, 2023MalfunctionRoche Diagnostics1823260-2023-00941
- DIMENSION®Feb 8, 2023MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2023-00051
- ELECSYS CK-MBJul 6, 2022MalfunctionRoche Diagnostics1823260-2022-01976
- ELECSYS CK-MB STAT IMMUNOASSAYDec 15, 2020MalfunctionRoche Diagnostics1823260-2020-03232
- CKMBJun 5, 2020MalfunctionRoche Diagnostics1823260-2020-01370
- ELECSYS CK-MB STAT IMMUNOASSAYJan 29, 2019MalfunctionRoche Diagnostics1823260-2019-90066
- DIMENSION®Jan 9, 2019MalfunctionSiemens Healthcare Diagnostics Inc2517506-2019-00007
- ELECSYS CK-MB IMMUNOASSAYDec 19, 2018MalfunctionRoche Diagnostics1823260-2018-05004
Event type breakdown
Recalls
2 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.TerminatedMay 4, 2018
Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Z-1672-2018 · View FDA record ↗ - BioCheck IncTerminatedMar 11, 2011
CK-MB ELISA kit ;
Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
Z-1641-2011 · View FDA record ↗
Registered firms
15 firms currently registered for this product code
Medica Corp.
BEDFORD, MA, US
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Diamond Diagnostics Inc.
Budapest, HU
Sebia
EVRY Essonne, FR
Currier Plastics
Auburn, NY, US
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Teco Diagnostics
ANAHEIM, CA, US
Helena Laboratories, Corp.
BEAUMONT, TX, US
Monobind, Inc.
Lake Forest, CA, US
Inpeco Sa
Novazzano Ticino, CH
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
510(k) clearances
40 clearances for this product code
- Siemens Healthcare DiagnosticsSep 18, 2015
K143720 · Dimension Vista MMB Assay
- Medica CorporationMay 13, 2014
K130080 · EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
- Roche DiagnosticsMay 8, 2014
K140404 · ELECSYS CK-MB STAT IMMUNOASSAY
- Roche DiagnosticsOct 18, 2013
K132571 · ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
- Olympus Life & Material Science Europa GmbH (IrishJun 4, 2007
K070835 · OLYMPUS CK-MB REAGENT
- Helena LaboratoriesOct 11, 2002
K022757 · SPIFE CK KIT, MODEL 3332, 3333
- Roche Diagnostics Corp.Aug 29, 2002
K022654 · MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
- Boehringer Mannheim Corp.Dec 17, 1997
K974421 · ELECSYS CK-MB STAT