Alco-Screen02

Basic Information

• Brand Name: Alco-Screen02
• Primary DI: 00737051863109
• Version / Model: 56001
• Company Name: CHEMATICS, INC.
• Labeler DUNS: 196929947
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 67095d2e-7d6a-4865-bbfb-8ccc03dc8e8d

Device Description

ALCO-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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	862.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62049	Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of ethyl alcohol (ETOH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to assess for alcohol intoxication and in the management of alcoholism. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00737051863109	GS1
Package	00737051863116	GS1	Box	24	In Commercial Distribution
Package	00737051863123	GS1	Case	12	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K121256	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 80 Degrees Fahrenheit