Home › Device types › LAO
Enzyme Immunoassay, Methotrexate
FDA product code LAO · Class U · Unknown
17
Registered devices
19
Adverse events
2
Recalls
10
510(k) clearances
Devices with this code
ABBOTT — ABBOTT LABORATORIESABBOTT — ABBOTT LABORATORIESARK™ Methotrexate Assay — ARK DIAGNOSTICS INCARK™ Methotrexate II Assay — ARK DIAGNOSTICS INCONLINE TDM Methotrexate — Roche Diagnostics GmbHARK™ Methotrexate II Control — ARK DIAGNOSTICS INCSyva® Emit® Methotrexate Assay — Siemens Healthcare Diagnostics Inc.ARK™ Methotrexate Assay (c-pack) — ARK DIAGNOSTICS INCARK™ Methotrexate II Control — ARK DIAGNOSTICS INCARK™ Methotrexate II Control — ARK DIAGNOSTICS INCARK™ Methotrexate II Dilution Buffer — ARK DIAGNOSTICS INCARK™ Methotrexate II Assay — ARK DIAGNOSTICS INCARK™ Methotrexate Assay — ARK DIAGNOSTICS INCONLINE TDM Methotrexate — Roche Diagnostics GmbHARK™ Methotrexate Assay — ARK DIAGNOSTICS INCARK™ Methotrexate II Calibrator — ARK DIAGNOSTICS INCABBOTT — ABBOTT LABORATORIES
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-03-08 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of |
| 2007-03-20 | Abbott Diagnostic International, Ltd. | Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P. |
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