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05/04/2023
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NHTSA product lists
Section 40.229 allows screening devices to be used for an alcohol screening test, provided the device is included by the National Highway Traffic Safety Administration on its “Conforming Products List of Alcohol Screening Devices.”
The current list of approved devices was published in the Federal Register on June 14, 2012.
Agency Contact: | Ms. De Carlo Ciccel Behavioral Research Division (NTI-131) National Highway Traffic Safety Administration 1200 New Jersey Avenue SE Washington, DC 20590 Telephone: (202) 366-1694 |
Following is the current list of alcohol screening devices.
Distributors/manufacturers | Devices |
---|---|
AK Solutions, USA, LLC., Palisades Park, New Jersey1 |
|
Alco Check International, Hudsonville, Michigan |
|
Akers Biosciences, Inc., Thorofare, New Jersey |
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Alcohol Countermeasure Systems Corp., Toronto, Ontario, Canada |
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BAC Solutions, Inc., Birmingham, Michigan |
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B.E.S.T. Labs., Boardman, Ohio |
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Chematics, Inc., North Webster, Indiana |
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CMI, Inc., Owensboro, Kentucky |
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Express Diagnostics Int'l, Inc., Blue Earth, Minnesota |
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First Innovative Technology Group, Ltd., Hong Kong |
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Guth Laboratories, Inc., Harrisburg, Pennsylvania |
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Han International Co., Ltd.,2 Seoul, Korea |
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KHN Solutions, LLC, San Francisco, California |
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Lion Laboratories, Ltd., Wales, United Kingdom |
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OraSure Technologies, Inc., Bethlehem, Pennsylvania |
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PAS Systems International, Inc., Fredericksburg, Virginia |
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Q3 Innovations, Inc., Independence, Iowa |
|
Repco Marketing, Inc., Raleigh, North Carolina |
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Seju Engineering Co., Taejeon, Korea |
|
Skyfine Inc., Ltd., Kwai Chung, NT, Hong Kong |
|
Sound Off, Inc., Hudsonville, Michigan |
|
Varian, Inc., Lake Forest, California |
|
1The AlcoMate was manufactured by Han International of Seoul, Korea, but marketed and sold in the U.S. by AK Solutions. | |
2Manufactured by Seju Engineering, Korea. | |
3Han International does not market or sell devices directly in the U.S. market. Other devices manufactured by Han International are listed under AK Solutions, Inc. and Q3 Innovations, Inc. | |
4Manufactured by Sentech Korea Corp. | |
5These devices utilize replaceable semiconductor detectors. Instead of re-calibrating the device, a new calibrated detector can be installed. The device comes with 4 detectors including the one that was already installed. | |
6These devices utilize replaceable semiconductor detectors. Instead of re-calibrating the device, a new calibrated detector can be installed. This device comes with 5 detectors including the one that was already installed. | |
7While these devices are still being sold, they are no longer manufactured or supported. | |
8The Breath Alcohol ? .02 Detection System consists of a single-use disposable breath tube used in conjunction with an electronic analyzer that determines the test result. The electronic analyzer and the disposable breath tubes are lot specific and manufactured to remain calibrated throughout the shelf-life of the device. This screening device cannot be used after the expiration date. | |
9While the ALCO-SCREEN 02TM saliva-alcohol screening device manufactured by Chematics, Inc. passed the requirements of the Model Specifications when tested at 40 °C (104 °F), the manufacturer has indicated that the device cannot exceed storage temperatures of 27 °C (80 °F). Instructions to this effect are stated on all packaging accompanying the device. Accordingly, the device should not be stored at temperatures above 27 °C (80 °F). If the device is stored at or below 27 °C (80 °F) and used at higher temperatures (i.e., within a minute), the device meets the Model Specifications and the results persist for 10-15 minutes. If the device is stored at or below 27 °C (80 °F) and equilibrated at 40 °C (104 °F) for an hour prior to sample application, the device fails to meet the Model Specifications. Storage at temperatures above 27 °C (80 °F), for even brief periods of time, may result in false negative readings. | |
10While this device passed all of the requirements of the Model Specifications, readings should be taken only after the time specified by the manufacturer. For valid readings, the user should follow the manufacturer's instructions. Readings should be taken one (1) minute after a sample is introduced at or above 30 °C (86 °F); readings should be taken after two (2) minutes at 18 °C-29 °C (64.4 °F-84.2 °F); and readings should be taken after five (5) minutes when testing at temperatures at or below 17 °C (62.6 °F). If the reading is taken before five (5) minutes has elapsed under the cold conditions, the user is likely to obtain a reading that underestimates the actual saliva-alcohol level. |
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