Home › Device types › JHY
Colorimetric Method, Cpk Or Isoenzymes
FDA product code JHY · Class 2 · Clinical Chemistry
21
Registered devices
51
Adverse events
2
Recalls
40
510(k) clearances
Devices with this code
Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge — Siemens Healthcare Diagnostics Inc.Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge — Siemens Healthcare Diagnostics Inc.SPIFE CK-20,40 Gel Kit — HELENA LABORATORIES CORPORATIONQuickGel CK Vis Gel Kit — HELENA LABORATORIES CORPORATIONElecsys CK-MB — Roche Diagnostics GmbHDimension Vista® Flex® reagent cartridge MMB — Siemens Healthcare Diagnostics Inc.Blade Applicator Kit, 20 Sample — HELENA LABORATORIES CORPORATIONBlade Applicator Kit, 20 Sample — HELENA LABORATORIES CORPORATIONCK-MB AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.SPIFE CK-20,40 Gel Kit — HELENA LABORATORIES CORPORATIONElecsys CKMB Immunoassay — Roche Diagnostics GmbHCalSet CK-MB — Roche Diagnostics GmbHBlade Applicator Kit, 20 Sample — HELENA LABORATORIES CORPORATIONCK-MB AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.CK-MB AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Monobind AccuLite CKMB CLIA Kit - 96 Wells — MONOBIND, INC.AU — Beckman Coulter, Inc.Elecsys CKMB STAT Immunoassay — Roche Diagnostics GmbHBlade Applicator Kit, 20 Sample — HELENA LABORATORIES CORPORATIONElecsys CKMB STAT CalSet — Roche Diagnostics GmbHSPIFE CK Reagent Kit — HELENA LABORATORIES CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | 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 |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
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