Alco-Screen
GUDID 00737051654806
ALCO-SCREEN is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates 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
CHEMATICS, INC.
Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical| Primary Device ID | 00737051654806 |
| NIH Device Record Key | c36a90ca-157e-4e39-b099-b394d6330337 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alco-Screen |
| Version Model Number | 55001 |
| Company DUNS | 196929947 |
| Company Name | CHEMATICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com | |
| Phone | 1-800-348-5174 |
| info@chematics.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00737051654806 [Primary] |
| GS1 | 00737051654813 [Package] Package: Box [24 Units] In Commercial Distribution |
| GS1 | 00737051654820 [Package] Contains: 00737051654813 Package: Case [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121247
FDA Product Code
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-29 |
Devices Manufactured by CHEMATICS, INC.
| 00737051548327 - Chemcard Cholesterol | 2018-07-06 The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify el |
| 00737051654806 - Alco-Screen | 2018-07-06ALCO-SCREEN is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates 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 |
| 00737051654806 - Alco-Screen | 2018-07-06 ALCO-SCREEN is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The |
| 00737051736922 - Chemcard Glucose | 2018-07-06 The Chemcard™ Glucose Test is intended for use as a rapid, in vitro method for early identification of abnormal fasting plasma |
| 00737051863109 - Alco-Screen02 | 2018-07-06 ALCO-SCREEN02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects rel |
Trademark Results [Alco-Screen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALCO-SCREEN 86721145 5319885 Live/Registered |
Chematics, Inc. 2015-08-11 |
 ALCO-SCREEN 74723872 2008063 Dead/Cancelled |
Chem-Elec Inc. 1995-09-01 |
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