Alco-Screen02
Alco-Screen 02 is a saliva test for detecting ethyl alcohol at a threshold corresponding to a blood alcohol concentration of 0.02% or higher. It provides a qualitative screening result used…
Alco-Screen 02 is a saliva test for detecting ethyl alcohol at a threshold corresponding to a blood alcohol concentration of 0.02% or higher. It provides a qualitative screening result used in the diagnosis of alcohol intoxication. The test is intended for use outside the body.
Alcohol in the saliva undergoes an enzymatic oxidation reaction on the test strip. A linked color producing reaction creates a visible change that the user reads to determine the screening result. Each strip is individually packaged and is discarded after one use.
Listed Item
ALCO-SCREEN02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative blood alcohol concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in-vitro diagnostic use. The assay is a disposable test for one-time use. 510K Cleared – CliaWaived
Result Type
The strip indicates whether the screening threshold has been reached rather than giving a numerical alcohol concentration. It is available for over the counter use and requires no electronic reader to interpret the visible reaction.
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 | Chematics, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K121256 |
| Record published | 2016-09-29 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 50 to 80 °F |
| Packaging | Box of 24, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 56001 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121247 | 2013-03-22 |
| K121256 | 2012-09-12 |
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.