Chematics Inc.

P.O. Box 293, 46555 North Webster, IN
4519 State Rd. 13 South, 46555 North Webster, IN
USA
Telephone +1 574 8342406
Fax +1 574 8347427
info@chematics.com

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03 Diagnostic Tests
03.01 Clinical chemistry
03.01.04 Rapid tests in clinical chemistry

Rapid tests in clinical chemistry

Saliva Alchohol Testing
Whole Blood Testing
Chemcard™ Cholesterol Test
Alco-Screen® / Alco-Screen® 02 Control Set

Our products

Product category: Rapid tests in clinical chemistry
Saliva Alchohol Testing
Alco-Screen® is a rapid, highly sensitive method to detect the presence of alcohol in saliva and provide an approximation of relative blood alcohol concentration. Since it is well established that the concentration of alcohol in saliva is very close to that in the blood, saliva is the preferred specimen for alcohol testing, allowing for greater detection sensitivity than breath testing methods. Alco-Screen® is a simple, one-step, 2 minute test that requires no instrumentation, calibration or special training to be used effectively. It is convenient enough to be used any time, and in any place.

Alco-Screen® is FDA 510(k) cleared for home use and is a CLIA-waived testing device. Inappropriate consumption of alcohol can be a problem in many family, occupational, institutional and safety sensitive situations. Alco-Screen® is an easy yet effective tool for identifying alcohol consumption. Alco-Screen® can be used as a cost effective way to help minimize the risks associated with inappropriate alcohol consumption.

Chematics, Inc. invented the saliva alcohol test in 1988 and is the leading manufacturer of quality saliva alcohol testing devices. With millions of tests sold worldwide, you can count on Chematics as a trusted partner and Alco-Screen® as an essential component in your alcohol testing or ZERO TOLERANCE efforts. Our knowledgeable staff is on call to answer your questions.

Chematics offers third party control solutions that can be used to comply with CLIA regulations and/or to test the viability of the Alco-Screen® test device. The Alco-Screen® and Alco-Screen® 02 Controls are ideal for CAP proficiency in Hospitals and Labs.

Product category: Rapid tests in clinical chemistry
Whole Blood Testing
Chemcard™ Cholesterol Test: FDA 510(k) cleared on-the-spot fingerstick blood test for total cholesterol screening by medical professionals in the United States and CE marked for self-testing in the European Union under Annex IV, Article 3 of EC Directive 98/79/EC on IN VITRO Diagnostic Medical Devices. Learn More

Chemcard™ Glucose Test: FDA 510(k) cleared fingerstick test for screening fasting blood glucose by medical professionals and home testing in the United States and CE marked for self-testing in the European Union under Annex IV, Article 3 of EC Directive 98/79/EC on IN VITRO Diagnostic Medical Devices

Product category: Rapid tests in clinical chemistry
Chemcard™ Cholesterol Test
The Chemcard™ Cholesterol test is a complete, disposable, 3 minute test intended for use for early detection of elevated blood cholesterol levels associated with increased risk of coronary artery disease. The National Heart, Lung and Blood Institute’s National Cholesterol Education Program classifies cardiac risk level based on total cholesterol concentration as follows:

Less than 200 mg/dL (5.2 mmol/l) – DESIRABLE blood cholesterol.
200 to 239 mg/dL (5.2 to 6.2 mmol/l) – BORDERLINE HIGH blood cholesterol.
240 mg/dL (6.2 mmol/l) or above – HIGH blood cholesterol.

The Chemcard™ Cholesterol test offers unsurpassed simplicity for instant determination of total cholesterol concentration in the diagnostically critical range of 150 to 300 mg/dL (3.9 to 7.8 mmol/l). The Chemcard™ Cholesterol test uses a single drop of whole blood from a fingerstick to provide a semiquantitative estimate of total cholesterol concentration without the use of an instrument, centrifuge or sample measurement. Results are interpreted after 3 minutes by matching the color of the test pad with one of the six color blocks calibrated in 25 mg/dL increments. The Chemcard™ Cholesterol test is the simplest, most cost effective cholesterol screening device available.

Due to FDA restrictions, the Chemcard™ Cholesterol test is available for use in the USA by medical professionals only.

The Chemcard™ Cholesterol test is CE marked for self-testing in the European Union under Annex IV, Article 3 of EC Directive 98/79/EC on IN VITRO Diagnostic Medical Devices.

Product category: Rapid tests in clinical chemistry
Alco-Screen® / Alco-Screen® 02 Control Set
x 4ml bottles (1 positive control, 1 negative control) for use with Alco-Screen® and Alco-Screen® 02 products

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About Us

Company details
The Company
Chematics is a privately held biotechnology company engaged in the development and manufacture of novel in-vitro diagnostic testing solutions and products that facilitate early identification of abnormal or unhealthy conditions. Founded in 1988, Chematics is located in North Webster, Indiana. Our objective as a company is to provide our customers worldwide with innovative easy to use products, at a reasonable price that are of the highest quality and are safe and effective when used for the purposes for which they are intended. Our success as a business depends upon achievement of this objective and upon continuous improvement of our products, processes and customer experiences.

Quality and Regulatory Information
Chematics is committed to being a good corporate citizen and of upholding our duty to the community and to our customers. It is our policy as a company to comply with all applicable laws and regulations relating to our manufacturing and business activities. Our ISO 13485:2003 certified Quality Management System is designed and implemented to achieve a state of continuous improvement and to conform to the standards of national and international regulations governing the manufacture and distribution of our medical devices. Our Alco-Screen®, Alco-Screen® 02, Chemcard™ Cholesterol and Chemcard™ Glucose products are manufactured in the U.S. and have received US FDA 510(k) clearance. The Chemcard™ Cholesterol and Chemcard™ Glucose test devices are CE marked for marketing in the EU under the IVD Directive 98/79/EC.

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