CHEMATICS, INC.

Address:HWY. 13 SOUTH,NORTH WEBSTER,IN,46555,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (DIC) (2) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (1) Glucose Oxidase, Glucose (CGA) (1)

Premarket Exempt

Clear

Chemcard Cholesterol - 00737051548303 Catalog Number :

Device Description : The CHEMCARD™ Cholesterol Test provides a preliminarysemi-quantitative analytica The CHEMCARD™ Cholesterol Test provides a preliminarysemi-quantitative analytical test result that can be used to identify elevated blood cholesterollevels associated with increased risk of coronary artery disease.510K Cleared for Professional Use Only.

Device Class : 1

Duns Number: 196929947

Premarket Exempt : No

Product Code : CHH

Prescription Use : No

Device Count : 1

Alco-Screen - 00737051654806 Catalog Number :

Device Description : ALCO-SCREEN is a semi-quantitative screening test used to estimate theBlood Alco ALCO-SCREEN is a semi-quantitative screening test used to estimate theBlood Alcohol Concentration (BAC) using human saliva. The test stripestimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels.Results are used in the diagnosis of alcohol use or intoxication.For in vitro diagnostic use.510K Cleared - CliaWaived

Device Class :

Duns Number: 196929947

Premarket Exempt : No

Product Code : DIC

Prescription Use : No

Device Count : 1

Chemcard Glucose - 00737051736908 Catalog Number :

Device Description : The Chemcard™ Glucose Test is intended for use as arapid, in vitro method for ea The Chemcard™ Glucose Test is intended for use as arapid, in vitro method for early identification of abnormal fastingplasma glucose concentration which can be a sign of diabetesor other medical problems. The Chemcard™ Glucose Test providesa preliminary, semi-quantitative result using fingerstick bloodas the test specimen.510K Cleared - CliaWaived

Device Class : 2

Duns Number: 196929947

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 1

Alco-Screen02 - 00737051863109 Catalog Number :

Device Description : ALCO-SCREEN02 is a qualitative screening test used to detect thepresence of ethy ALCO-SCREEN02 is a qualitative screening test used to detect thepresence of ethyl alcohol in human saliva. The test detects relative bloodalcohol concentrations (BAC) greater than or equal to 0.02%. Results areused for the diagnosis of alcohol intoxication. For in-vitro diagnostic use.The assay is a disposable test for one-time use.510K Cleared - CliaWaived

Device Class :

Duns Number: 196929947

Premarket Exempt : No

Product Code : DIC

Prescription Use : No

Device Count : 1

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