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Elecsys CKMB STAT Immunoassay
Roche Diagnostics GmbH · Model 5957648160 · UDI-DI 04015630934638
JHY
Prescription
1
510(k) clearances
51
Adverse events
2
Recalls
11
Facilities
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 MMB, Dimension Sirol |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.