Alco-Screen

GUDID 00737051654806

Ethanol (ETOH) IVD, kit, colorimetric, rapid

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

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 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

DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Steralize Prior To Use	false
Device Is Sterile	false

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

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