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Calibrators, Ethyl Alcohol
FDA product code DNN · Class 2 · Clinical Toxicology
23
Registered devices
0
Adverse events
2
Recalls
7
510(k) clearances
Devices with this code
DRI Negative Alcohol Calibrator — Microgenics CorporationPOINTE SCIENTIFIC Alcohol Standard — HORIBA INSTRUMENTS INCORPORATEDDRI 100 mg/dL Alcohol Calibrator — Microgenics CorporationEthanol Standard, Level D — VERICHEM LABORATORIES, INC.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Alinity — ABBOTT LABORATORIESCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESCAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPointe Ethyl Alcohol Calibrator (100 mg/dL) — HORIBA INSTRUMENTS INCORPORATEDSynchron — Beckman Coulter, Inc.DRI 100 mg/dL Alcohol Calibrator — Microgenics CorporationCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321 — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — ABBOTT LABORATORIESCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — ABBOTT LABORATORIESDRI Negative Alcohol Calibrator — Microgenics CorporationUrine Calibrator Set — Chromsystems Instruments + Chemicals GmbHEthanol Standard Kit — VERICHEM LABORATORIES, INC.Ethyl Alcohol DAU Calibrator, Calibrator #2 — LIN-ZHI INTERNATIONAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-07-26 | Hospira, Inc. | The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropri |
| 2008-03-27 | EMD Chemicals Inc | Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard. |
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