Emit® II Plus Ethyl Alcohol Assay
Emit ® II Plus Ethyl Alcohol Assay labeled with the Beckman Coulter® name
2manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | DIC |
| Device type | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K010960 |
| Record published | 2016-09-24 |
| Record revised | 2024-04-26 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10445451 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Immunalysis | Immunalysis Corporation | 4 |
| Wondfo | Wondfo USA Co., Ltd. | 4 |
| Ethanol Gen.2 | Roche Diagnostics Gmbh | 2 |
| Ethyl Alcohol Enzymatic Assay | LIN-ZHI International, Inc. | 2 |
| Wondfo Saliva Alcohol Test | Wondfo USA Co., Ltd. | 2 |
| Pointe Ethyl Alcohol Reagent Set | Horiba Instruments Incorporated | 2 |
| Pointe Scientific Alcohol | Horiba Instruments Incorporated | 2 |
| co-innovation | Co-Innovation Biotech Co., Ltd. | 1 |
| Ethanol Gen2 | Roche Diagnostics Gmbh | 1 |
| Teco Diagnostics | Teco Diagnostics | 1 |
| Atellica CH Ethanol (EtohC) | Siemens Healthcare Diagnostics Inc | 1 |
| MP Saliva Alcohol Test Strip | Rapid Diagnostics, Inc. | 1 |
Showing 12 of 27. All products under Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-02-14 | Class II | Under Investigation by firm | The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. | 1124 | 2024-02-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.