Alco-Screen02

GUDID 00737051863109

Ethanol (ETOH) IVD, kit, colorimetric, rapid

Primary Device ID	00737051863109
NIH Device Record Key	67095d2e-7d6a-4865-bbfb-8ccc03dc8e8d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Alco-Screen02
Version Model Number	56001
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	00737051863109 [Primary]
GS1	00737051863116 [Package] Package: Box [24 Units] In Commercial Distribution
GS1	00737051863123 [Package] Contains: 00737051863116 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

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00737051863109 - Alco-Screen02	2018-07-06ALCO-SCREEN02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative blood alcohol concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in-vitro diagnostic use. The assay is a disposable test for one-time use. 510K Cleared - CliaWaived
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