Teco Diagnostics
The Teco Saliva Alcohol Test is a visually read screening strip for alcohol in human saliva. It gives semiquantitative results by comparing the reacted test pad with a color chart printed…
The Teco Saliva Alcohol Test is a visually read screening strip for alcohol in human saliva. It gives semiquantitative results by comparing the reacted test pad with a color chart printed on the strip pouch.
The strip has a reactive pad containing alcohol oxidase, peroxidase and the color indicator tetramethylbenzidine. Coupled enzyme reactions change the pad color in the presence of ethanol, with the color corresponding to the amount of alcohol in the sample.
Listed Item
Alcohol Dipstick Test Kit (25 Tests)
Reading the Result
Each foil pouch contains one strip. The result is read at two minutes against five reference levels: negative, 0.02%, 0.04%, 0.08% and 0.3%, expressed as relative blood alcohol concentration. The test uses saliva rather than a collected blood sample.
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 | Teco Diagnostics, 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, Manufacturer, Exporter |
| 510(k) | K111206 |
| Record published | 2022-09-07 |
| Record revised | 2022-11-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Distribution end date | 2022-09-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D770-25 | Withdrawn |
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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111206 | 2011-10-04 |
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.