FDA.reportPublic FDA data

Urine Control

Primary DI
04250317535795
Brand
Urine Control
Company
Chromsystems Instruments + Chemicals GmbH
Model
0369
Catalog number
0369
Device description
MassCheck® Ethyl Glucuronide, Ethyl Sulfate, Urine Control Level III
Published
2020-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DKCAlcohol Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKCAlcohol Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250317535795PackageGS15In Commercial Distribution
04250317546111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317535795042503175357954250317535795
04250317546111042503175461114250317546111

GMDN Terms#

Term, Definition table
TermDefinition
Ethyl glucuronide (EtG) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of ethyl glucuronide (EtG), a metabolite of ethanol alcohol (ETOH), in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-18 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4989189300mailbox@chromsystems.de

Regulatory Flags#

DUNS number
328712260
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250317537591Reagent80610806102020-08-27
04250317501554Prefilter15009150092026-01-22
04250317501578Prefilter15011150112026-01-22
04250317536204Prefilter15061150612026-01-22
04250317537577Prefilter15071150712026-01-22
04250317554611Precolumn18010180102026-01-22
04250317555281Prefilter15013150132026-01-22
04250317558022Prefilter57016570162026-01-22
04250317558084Restrictor Capillary55018550182026-01-22
04250317555137Plasma Control0250-XT20250-XT22025-07-31
04250317555151Plasma Control0251-XT20251-XT22025-07-31
04250317510174Tube48010480102025-07-31
04250317552747Dried Blood Control019501952025-07-31
04250317552754Dried Blood Control019601962025-07-31
04250317552761Dried Blood Control019701972025-07-31
04250317554819Dried Blood Control029502952025-07-31
04250317554826Dried Blood Control029602962025-07-31
04250317554833Dried Blood Control029702972025-07-31
04250317554994Plasma Calibrator Set92025-XT292025-XT22025-07-31
04250317555120Plasma Control0250-XT20250-XT22025-07-31

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
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
15099590222727SynchronBeckman Coulter, Inc.DKC2016-08-24