FDA.reportPublic FDA data

POINTE SCIENTIFIC Alcohol Standard

Primary DI
00811727010087
Brand
POINTE SCIENTIFIC Alcohol Standard
Company
HORIBA INSTRUMENTS INCORPORATED
Model
A7504-STD
Catalog number
A7504-STD
Device description
The Alcohol standard is intended as a means of calibrating various ethanol assay methods.
Published
2016-08-31
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
K882117000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882117000ETHYL ALCOHOL STANDARDVerichem Laboratories, Inc.1988-08-04DNN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727010087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727010087008117270100878117270100870811727010087

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be 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@medtest.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
00811727017413Pointe Ethyl Alcohol Calibrator (100 mg/dL)HORIBA INSTRUMENTS INCORPORATEDDNN2020-09-25
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
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