Home › Device types › KLR
Enzyme Immunoassay, Lidocaine
FDA product code KLR · Class 2 · Clinical Toxicology
8
Registered devices
2
Adverse events
1
Recalls
17
510(k) clearances
Devices with this code
Atellica CH LIDO — Siemens Healthcare Diagnostics Inc.Dimension Vista® Flex® reagent cartridge LIDO — Siemens Healthcare Diagnostics Inc.Dimension® Flex® reagent cartridge LIDO — Siemens Healthcare Diagnostics Inc.QMS Lidocaine Immunoassay — Microgenics CorporationSyva® Emit® Disopyramide Assay — Siemens Healthcare Diagnostics Inc.Lidocaine — Roche Diagnostics GmbHSyva® Emit® Lidocaine Assay — Siemens Healthcare Diagnostics Inc.ONLINE TDM Lidocaine — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-26 | Siemens Healthcare Diagnostics, Inc. | Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the o |
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