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Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
FDA product code DIC · Class 2 · Clinical Toxicology
50
Registered devices
9
Adverse events
6
Recalls
33
510(k) clearances
Devices with this code
Alco-Screen — CHEMATICS, INC.Alco-Screen02 — CHEMATICS, INC.Immunalysis — IMMUNALYSIS CORPco-innovation — Co-Innovation Biotech Co., LtdCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONco-innovation — Co-Innovation Biotech Co., Ltdco-innovation — Co-Innovation Biotech Co., LtdPointe Ethyl Alcohol Reagent Set — HORIBA INSTRUMENTS INCORPORATEDAlcoCheck — Express Diagnostic Int'l, Inc.Accustrip Saliva Alcohol Test — JANT PHARMACAL CORPORATIONImmunalysis — IMMUNALYSIS CORPCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421 — CAROLINA LIQUID CHEMISTRIES CORPORATIONQ.E.D. Saliva Alcohol Test A150 — Orasure Technologies, Inc.Wondfo — WONDFO USA CO., LTD.Ethyl Alcohol Enzymatic Assay — LIN-ZHI INTERNATIONAL, INC.TECO DIAGNOSTICS — TECO DIAGNOSTICSEthanol Gen.2 — Roche Diagnostics GmbHWondfo — WONDFO USA CO., LTD.Wondfo — WONDFO USA CO., LTD.Dimension® Flex® reagent cartridge ETOH — Siemens Healthcare Diagnostics Inc.co-innovation — Co-Innovation Biotech Co., LtdWondfo — WONDFO USA CO., LTD.co-innovation — Co-Innovation Biotech Co., Ltd
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2020-02-14 | Siemens Healthcare Diagnostics, Inc. | The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. |
| 2019-01-16 | Carolina Liquid Chemistries | Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not f |
| 2019-01-16 | Carolina Liquid Chemistries | |
| 2019-01-11 | Lin-Zhi International Inc | Shelf life of the product may be reduced due to degradation of the assay. |
| 2010-11-01 | Express Diagnostics Int'l., Inc. | Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the alcohol test strip manufacturer on October 27, 20 |
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