FDA.reportPublic FDA data

Ethyl Alcohol DAU Control, Level 2 Control

Primary DI
B07602250
Brand
Ethyl Alcohol DAU Control, Level 2 Control
Company
LIN-ZHI INTERNATIONAL, INC.
Model
0225
Catalog number
0225
Device description
5mL/bottle.Concentration: 300 mg/dL of Ethanol.
Published
2016-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
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
B07602250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, calibrator/controlA material(s) which is used to both establish known reference points and to verify the performance of an assay intended to be used for the qualitative and/or qualitative detection 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

Regulatory Flags#

DUNS number
840839190
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00850624008650LZI Fentanyl Qualitative CalibratorD26784D267842025-10-13
00850624008667LZI Fentanyl Level 1 ControlD26785D267852025-10-13
00850624008674LZI Fentanyl Level 2 ControlD26786D267862025-10-13
00850624008681LZI Fentanyl III Enzyme ImmunoassayD29739D297392025-10-13
00850624008636Fentanyl Control Set10426667190104266671902025-06-06
B07600400Amphetamines Enzyme Immunoassay004000402016-07-05
B07600410Amphetamines Enzyme Immunoassay004100412016-07-05
B07601000Amphetamines 500 Enzyme Immunoassay010001002016-07-05
B07601010Amphetamines 500 Enzyme Immunoassay010101012016-07-05
B07601600Ecstasy Enzyme Immunoassay016001602016-07-05
B07601610Ecstasy Enzyme Immunoassay016101612016-07-05
B07601620Ecstasy DAU Calibrator, Low Calibrator016201622016-07-05
B07601630Ecstasy DAU Calibrator, Cutoff Calibrator016301632016-07-05
B07601640Ecstasy DAU Calibrator, Intermediate Calibrator016401642016-07-05
B07601650Ecstasy DAU Calibrator, High Calibrator016501652016-07-05
B07601670Ecstasy DAU Control, Level 1 Control016701672016-07-05
B07601680Ecstasy DAU Control, Level 2 Control016801682016-07-05
B0760002C0Cannabinoids DAU Calibrator, Negative Calibrator0002c0002c2016-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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