AlcoBreath Tube
AlcoBreath Tube is a disposable breath alcohol screening test used in medical and therapeutic programs. It provides a semiquantitative estimate of alcohol concentration in exhaled breath.…
AlcoBreath Tube is a disposable breath alcohol screening test used in medical and therapeutic programs. It provides a semiquantitative estimate of alcohol concentration in exhaled breath. The result is preliminary and is not intended as evidential testing.
Breath passes over reagent-treated silica gel, producing a color change when alcohol reaches the test’s detection range. The length of the stained area is proportional to the alcohol concentration and is read visually after the specified test period.
Listed Item
Disposable breath alcohol test
Configurations and Timing
ABT08 estimates levels up to 0.08%, while ABT15 estimates levels up to 0.15%. The user blows for one minute, and the test time is two minutes. Each device is intended for one use.
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (2), Hunan (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dong Guan EEK Electronic Technology Co., Limited | Dong Guan | Guangdong | Contract manufacturer | 2 |
| Fujian Ruili Electronics Co., Ltd. | Ningde | Fujian | Contract manufacturer | 2 |
| Huizhou Maxway Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 2 |
| Hanwei Electronics Group Corporation | Zhengzhou | Henan | Contract manufacturer | 1 |
| Sunton Electronics Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 1 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Changsha U DE Toptech Electronic Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 3 |
| E-Business International Inc. | Shenzhen | Guangdong | Exporter | 2 |
| Rayco Electronic Ltd. | Dong Guan | Guangdong | Manufacturer | 2 |
| Shenzhen Well Electric Co., Limited | Shenzhen | Guangdong | Manufacturer | 2 |
Showing 12 of 16. All 16 manufacturers in China registered for Devices, Breath Trapping, Alcohol
Record
| Listed by | AlcoPro Inc, United States |
|---|---|
| FDA product code | DJZ |
| Device type | Devices, Breath Trapping, Alcohol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3050 |
| Establishment | Manufacturer |
| 510(k) | K102225 |
| Record published | 2022-09-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Packaging | Pack of 100 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ABT08 | 25 | In distribution | |
| ABT08 | 100 | In distribution | |
| ABT15 | 25 | In distribution | |
| ABT15 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Soberlink | Soberlink Healthcare LLC | 7 |
| Checkpoint | AlcoPro Inc | 6 |
| co-innovation | Co-Innovation Biotech Co., Ltd. | 1 |
| Easy@Home Fuel Cell Breathalyzer | Easy Healthcare Corporation | 1 |
| Accutest Breath Alcohol Detector | Jant Pharmacal Corp. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102225 | 2011-04-06 |
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.