FDA.reportPublic FDA data

WHOLE BLOOD ETHANOL CONTROL LEVEL 2

Primary DI
00817238011575
Brand
WHOLE BLOOD ETHANOL CONTROL LEVEL 2
Company
CLINIQA CORPORATION
Model
93212
Device description
WHOLE BLOOD ETHANOL CONTROL LEVEL 2
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
00817238011575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817238011575008172380115758172380115750817238011575

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
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
00817238011568WHOLE BLOOD ETHANOL CONTROL LEVEL1CLINIQA 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