Pointe Ethyl Alcohol Reagent Set
Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or…
Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
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 | Horiba Instruments Incorporated, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K032461 |
| Record published | 2020-09-25 |
| Record revised | 2025-10-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60-EA0440-1L | In distribution | |
| 60-EA0440-100 | 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 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 |
| Dimension Vista® Flex® reagent cartridge Etoh | Siemens Healthcare Diagnostics Inc | 1 |
Showing 12 of 27. All products under Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Carolina Liquid Chemistries | 510(k) number | 2019-01-16 | Class III | Nonconforming Material/Component | 14 kits | 2021-02-02 | |
| Carolina Liquid Chemistries | 510(k) number | 2019-01-16 | Class III | Nonconforming Material/Component | Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life. | 20 kits | 2021-02-02 |
| LIN-ZHI International, Inc. | 510(k) number | 2019-01-11 | Class III | Material/Component Contamination | Shelf life of the product may be reduced due to degradation of the assay. | 49 kits | 2021-03-22 |
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.