chematics.comALCO-SCREEN
CHEMATICS, INC.
CHEMATICS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1825396 | 1825396 | CHEMATICS, INC. | 1 | N | 2026-01-01 | HWY. 13 SOUTH NORTH WEBSTER IN US 46555 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00737051548303 | Chemcard Cholesterol - 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. | 1-800-348-5174 | info@chematics.com |
| 00737051548327 | Chemcard Cholesterol - The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify elevated blood cholesterol levels associated with increased risk of coronary artery disease. 510K Cleared for Professional Use Only. | 1-800-348-5174 | info@chematics.com |
| 00737051654806 | Alco-Screen - 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 | 1-800-348-5174 | info@chematics.com |
| 00737051736908 | Chemcard Glucose - 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 | 1-800-348-5174 | info@chematics.com |
| 00737051736922 | Chemcard Glucose - The Chemcard™ Glucose Test is intended for use as a rapid, in vitro method for early identification of abnormal fasting plasma glucose concentration which can be a sign of diabetes or other medical problems. The Chemcard™ Glucose Test provides a preliminary, semi-quantitative result using fingerstick blood as the test specimen. 510K Cleared - CliaWaived | 1-800-348-5174 | info@chematics.com |
| 00737051863109 | Alco-Screen02 - 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 | 1-800-348-5174 | info@chematics.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 3960 | 1369497939 | K943503 | CHEMCARD GLUCOSE TEST | CGA | 1996-07-23 |
| 3960 | 1880945024 | K864159 | SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD | CHH | 1988-06-10 |
| 3960 | 1393629811 | K121256 | ALCO-SCREEN 02 | DIC | 2012-09-12 |
| 3960 | 2058922564 | K121247 | ALCO-SCREEN | DIC | 2013-03-22 |
| 3960 | 1424811024 |
Product Codes Associated With Registrations#
PMN#
ALCO-SCREEN 02
CHEMATICS, INC.
GUDID#
Alco-Screen - 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
2016-09-29
Alco-Screen02 - 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
2016-09-29
Chemcard Cholesterol - 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.
2016-09-29
Chemcard Glucose - 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
2016-09-29
Chemcard Cholesterol - The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify elevated blood cholesterol levels associated with increased risk of coronary artery disease. 510K Cleared for Professional Use Only.
2016-09-29
Chemcard Glucose - The Chemcard™ Glucose Test is intended for use as a rapid, in vitro method for early identification of abnormal fasting plasma glucose concentration which can be a sign of diabetes or other medical problems. The Chemcard™ Glucose Test provides a preliminary, semi-quantitative result using fingerstick blood as the test specimen. 510K Cleared - CliaWaived
2016-09-29