FDA.reportPublic FDA data

Pointe Ethyl Alcohol Calibrator (100 mg/dL)

Primary DI
00811727017413
Brand
Pointe Ethyl Alcohol Calibrator (100 mg/dL)
Company
HORIBA INSTRUMENTS INCORPORATED
Model
60-EA0446-5
Catalog number
60-EA0446-5
Device description
Pointe Ethyl Alcohol Calibrator (100 mg/dL) 1 x 5 mL The Pointe Ethyl Alcohol Calibrators are for use as calibrators in the quantitation of the Pointe Ethyl Alcohol Reagent Set (Ref# 60-EA0440-100/60-EA0440-1L) on 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
DNNCalibrators, Ethyl Alcohol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DNNCalibrators, Ethyl AlcoholClinical 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
00811727017413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727017413008117270174138117270174130811727017413

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.

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
04250317536754Urine Calibrator SetChromsystems Instruments + Chemicals GmbHDNN2019-03-22
00380740135355AlinityABBOTT LABORATORIESDNN2018-07-11
00852553007247Ethanol Standard KitVERICHEM LABORATORIES, INC.DNN2018-01-16
00852553007346Ethanol Standard, Level DVERICHEM LABORATORIES, INC.DNN2018-01-16
00884883005129DRI Negative Alcohol CalibratorMicrogenics CorporationDNN2016-09-12
00884883005198DRI 100 mg/dL Alcohol Calibrator Microgenics CorporationDNN2016-09-12
00884883011540DRI 100 mg/dL Alcohol Calibrator Microgenics CorporationDNN2016-09-12
00884883011564DRI Negative Alcohol CalibratorMicrogenics CorporationDNN2016-09-12
00817302021332CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00817302021349CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00817302021356CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00817302021363CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00817302021370CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00817302021387CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00811727010087POINTE SCIENTIFIC Alcohol StandardHORIBA INSTRUMENTS INCORPORATEDDNN2016-08-31
15099590222079SynchronBeckman Coulter, Inc.DNN2016-08-24
10758750005048VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DNN2016-08-23
B07602230Ethyl Alcohol DAU Calibrator, Calibrator #2LIN-ZHI INTERNATIONAL, INC.DNN2016-07-05
00380740005511ARCHITECTABBOTT LABORATORIESDNN2016-06-06
00380740005528ARCHITECTABBOTT LABORATORIESDNN2016-06-06
00380740005535ARCHITECTABBOTT LABORATORIESDNN2016-06-06
00380740005542ARCHITECTABBOTT LABORATORIESDNN2016-06-06