FDA.reportPublic FDA data

Pointe Ethyl Alcohol Reagent Set

Primary DI
00811727017406
Brand
Pointe Ethyl Alcohol Reagent Set
Company
HORIBA INSTRUMENTS INCORPORATED
Model
60-EA0440-1L
Catalog number
60-EA0440-1L
Device description
Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
Published
2020-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K032461000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032461000ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221Lin-Zhi International, Inc.2003-10-03DIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727017406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727017406008117270174068117270174060811727017406

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen, using an enzyme spectrophotometry method. It is typically used to assess for alcohol intoxication and in the management of alcoholism.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-445-9853techservice@medtestdx.com

Regulatory Flags#

DUNS number
052845583
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811727018977POINTE Chemistry Calibrator SetC7506-15C7506-152026-05-01
00811727015716Pointe ALT for the BS48014-A7526-37514-A7526-3752020-05-28
00811727015747Pointe BUN on BS48014-B7552-60014-B7552-6002020-05-28
00811727015761Pointe Creatinine Enzymatic on BS48014-C7548-21614-C7548-2162020-05-28
00811727015785Pointe Creatine Kinase for BS48014-C7522-22014-C7522-2202020-05-28
00811727015808Pointe Creatinine for BS48014-C7539-43214-C7539-4322020-05-28
00811727015822Pointe Direct Bilirubin for BS48014-HB936-20014-HB936-2002020-05-28
00811727015853Pointe HbA1c for the BS48014-H7546-16014-H7546-1602020-05-28
00811727015709Pointe Alkaline Phosphatase on the BS48014-A7516-22514-A7516-2252020-05-28
00811727015723Pointe Amylase on BS480 Analyzer14-A7564-12014-A7564-1202020-05-28
00811727015730Pointe AST on the BS480 Analyzer14-A7561-37514-A7561-3752020-05-28
00811727015754Pointe Calcium Arsenazo for BS48014-C7529-36014-C7529-3602020-05-28
00811727015778Pointe Cholesterol on BS48014-C7510-48014-C7510-4802020-05-28
00811727015792Pointe Carbon Dioxide on the BS48014-C7502-16014-C7502-1602020-05-28
00811727015839Pointe GGT on BS48014-G7571-20014-G7571-2002020-05-28
00811727015846Pointe Glucose Hexokinase for BS48014-G7517-48014-G7517-4802020-05-28
00811727015860Pointe autoHDL for the BS48014-H7545-30014-H7545-4002020-05-28
00811727015877Pointe Homocysteine for BS48014-H7575-14414-H7575-1442020-05-28
00811727015884Pointe Total Iron for the BS48014-HI904-35014-HI904-3502020-05-28
00811727015693Pointe Albumin on BS480 Analyzer14-A7502-48014-A7502-4802020-05-28

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
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06970429841628co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
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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
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
B298409000AlcoCheckEXPRESS DIAGNOSTICS INT'L, INC.DIC2017-02-20