FDA.reportPublic FDA data

Alco-Screen

Primary DI
00737051654806
Brand
Alco-Screen
Company
CHEMATICS, INC.
Model
55001
Device description
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
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121247000ALCO-SCREENChematics, Inc.2013-03-22DIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00737051654813PackageGS124In Commercial Distribution
00737051654820PackageGS112In Commercial Distribution
00737051654806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00737051654813007370516548137370516548130737051654813
00737051654820007370516548207370516548200737051654820
00737051654806007370516548067370516548060737051654806

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, kit, colorimetric, rapidA 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 colorimetric method. This test is commonly used in the laboratory or in point-of-care analyses to assess for alcohol intoxication and in the management of alcoholism.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-348-5174info@chematics.com

Regulatory Flags#

DUNS number
196929947
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00737051863109Alco-Screen02560012016-09-29
00737051548303Chemcard Cholesterol430012016-09-29
00737051736908Chemcard Glucose470002016-09-29
00737051548327Chemcard Cholesterol430012016-09-29
00737051736922Chemcard Glucose470002016-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654089Atellica CH Ethanol (EtohC)Siemens Healthcare Diagnostics Inc.DIC2025-10-15
00816862024531WondfoWONDFO USA CO., LTD.DIC2024-05-23
10816862024538WondfoWONDFO USA CO., LTD.DIC2024-05-23
10673486000993TECO DIAGNOSTICSTECO DIAGNOSTICSDIC2022-09-07
06970429841444co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841536co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841628co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841703co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841802co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841901co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
00816862022995WondfoWONDFO USA CO., LTD.DIC2021-08-20
00816862023015WondfoWONDFO USA CO., LTD.DIC2021-08-20
10816862022992WondfoWONDFO USA CO., LTD.DIC2021-08-20
10816862023012WondfoWONDFO USA CO., LTD.DIC2021-08-20
06970429841611co-innovationCo-Innovation Biotech Co., LtdDIC2021-03-29
00811727017390Pointe Ethyl Alcohol Reagent SetHORIBA INSTRUMENTS INCORPORATEDDIC2020-09-25
00811727017406Pointe Ethyl Alcohol Reagent SetHORIBA INSTRUMENTS INCORPORATEDDIC2020-09-25
07613336121221Ethanol Gen.2Roche Diagnostics GmbHDIC2020-03-05
07613336157817Ethanol Gen.2Roche Diagnostics GmbHDIC2020-03-05
00816862022339WondfoWONDFO USA CO., LTD.DIC2020-02-20
10816862022336WondfoWONDFO USA CO., LTD.DIC2020-02-20
B2984090010AlcoCheckExpress Diagnostic Int'l, Inc.DIC2019-05-02
06970429841284co-innovationCo-Innovation Biotech Co., LtdDIC2019-03-22
26970429841288co-innovationCo-Innovation Biotech Co., LtdDIC2019-03-22
00628063401086Ethanol AssaySEKISUI DIAGNOSTICS, LLCDIC2018-11-28
00840937110355ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110362ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110379ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110386ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00817830022825MP Saliva Alcohol Test StripRAPID DIAGNOSTICS INCDIC2017-08-03