FDA.reportPublic FDA data

WHOLE BLOOD ETHANOL CONTROL LEVEL1

Primary DI
00817238011568
Brand
WHOLE BLOOD ETHANOL CONTROL LEVEL1
Company
CLINIQA CORPORATION
Model
93211
Device description
WHOLE BLOOD ETHANOL CONTROL LEVEL1
Published
2018-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DKCAlcohol Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKCAlcohol Control MaterialsClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912826000WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2Cala Diagnostics1991-07-26DKC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817238011568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817238011568008172380115688172380115680817238011568

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together may create a full general biochemistry profile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078742335
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
00817238010257LiquidQC NEPHROCHECK Control 839382024-06-05
00817238010332NEPHROCHECK Calibration Verification839392024-06-05
00817238010264NEPHROCHECK® Method Validation For VIDAS® 3839402019-01-29
00817238010271LIQUID QC LIPID CONTROL LEVEL 915012018-08-23
00817238010288LIQUID QC LIPID CONTROL LEVEL 2 915022018-08-23
00817238010295LIQUID QC LIPID CONTROL Bi-level 915052018-08-23
00817238011520LQC Cardiac Control CS, mini pack914492022-11-19
00817238011056hsCRP Wide Range Reagent855502018-08-23
00817238010103Tumor Marker Control level 3913032018-08-22
00817238010110Tumor Marker Control level 1 913012018-08-22
00817238010127Tumor Marker Control level 2913022018-08-22
00817238010134Tumor Marker Control Tri-level913042018-08-22
00817238010141ImmuTROL Serum Protein Contrl Tri-Level (Level 1,2 & 3)911042018-08-22
00817238010158Tumor Marker Control Tri-level913092018-08-22
00817238010172ImmuTROL Serum Protein Control-Bi-Level (Level 1 & 3)911052018-08-22
00817238010189ImmuTROL Serum Protein Contrl Level 1911012018-08-22
00817238010196ImmuTROL Serum Protein Contrl Level 2911022018-08-22
00817238010202ImmuTROL Serum Protein Contrl Level 3911032018-08-22
00817238010219hsCRP Serum Protein Control Level 1912012018-08-22
00817238010226hsCRP Serum Protein Control Level 2912022018-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811727017420Pointe Ethyl Alcohol Level 1 Control (50 mg/dL)HORIBA INSTRUMENTS INCORPORATEDDKC2020-09-25
00811727017437Pointe Ethyl Alcohol Level 2 Control (300 mg/dL)HORIBA INSTRUMENTS INCORPORATEDDKC2020-09-25
04250317544742Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317546067Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317546111Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317535771Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317535788Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317535795Urine ControlChromsystems Instruments + Chemicals GmbHDKC2020-08-06
04250317544971Serum ControlChromsystems Instruments + Chemicals GmbHDKC2020-07-30
04250317545213Serum ControlChromsystems Instruments + Chemicals GmbHDKC2020-07-30
04250317502209Serum ControlChromsystems Instruments + Chemicals GmbHDKC2020-07-30
04250317502223Serum ControlChromsystems Instruments + Chemicals GmbHDKC2020-07-30
00817238011575WHOLE BLOOD ETHANOL CONTROL LEVEL 2 CLINIQA CORPORATIONDKC2018-08-23
00380740135379AlinityABBOTT LABORATORIESDKC2018-07-11
00884883001015DRI 50 mg/dL Alcohol ControlMicrogenics CorporationDKC2017-10-30
00884883001039DRI 300 mg/dL Alcohol ControlMicrogenics CorporationDKC2017-10-30
00840937110683ImmunalysisIMMUNALYSIS CORPDKC2017-10-24
00840937110409ImmunalysisIMMUNALYSIS CORPDKC2017-09-07
00884883005129DRI Negative Alcohol CalibratorMicrogenics CorporationDKC2016-09-12
00884883005198DRI 100 mg/dL Alcohol Calibrator Microgenics CorporationDKC2016-09-12
00884883011540DRI 100 mg/dL Alcohol Calibrator Microgenics CorporationDKC2016-09-12
00884883011564DRI Negative Alcohol CalibratorMicrogenics CorporationDKC2016-09-12
00817302021332CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
00817302021349CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
00817302021356CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
00817302021363CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
00817302021370CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
00817302021387CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421CAROLINA LIQUID CHEMISTRIES CORPORATIONDKC2016-09-01
15099590222710SynchronBeckman Coulter, Inc.DKC2016-08-24
15099590222727SynchronBeckman Coulter, Inc.DKC2016-08-24