Ethanol Standard, Level D

Primary DI
00852553007346
Brand
Ethanol Standard, Level D
Company
VERICHEM LABORATORIES, INC.
Model
9674
Device description
Calibrator / Calibration Verifier
Published
2018-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00852553007346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852553007346008525530073468525530073460852553007346

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-552-5859customerservice@verichemlabs.com

Regulatory Flags#

DUNS number
189023351
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852553007049Enzymer Verifier Kit94302016-11-29
00852553007056Enzymer ER Verifier Kit94102016-11-29
00852553007131Enzymer ER Verifier, Level G94172016-11-29
00852553007001Total Protein/Albumin Standard Kit, Level F946694662016-11-15
00852553007018Matrix Plus Cholestereol Reference Kit95502016-11-29
00852553007025HDL Cholesterol Verifier Kit95602016-11-29
00852553007032Urine Uric Acid Standard Kit90202016-11-29
00852553007063Bilirubin Standard Kit94502016-11-29
00852553007070Bilirubin Standard, Level F94362016-11-29
00852553007087Ammonia / Iron Standard Kit90402016-11-29
00852553007094Serum ISE Standard Kit92402016-11-29
00852553007100Carbon Dioxide Standard Kit92102016-11-29
00852553007117BR2 Bilirubin Calibrator94592016-11-29
00852553007124Lipoprotein Verifier Kit95702016-11-29
00852553007148Matrix Plus Chemistry Reference Kit95002016-11-29
00852553007155Total Protein / Albumin Standard Kit94602016-12-05
00852553007162Electrolyte Standard Kit92002018-01-16
00852553007179Urine Chemistry Standard Kit90002018-01-16
00852553007186LDL Cholesterol ExR Verifier Kit95802018-01-16
00852553007209Chemistry Reference Kit95102018-01-16

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
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