FDA.reportPublic FDA data

COPPER (Cu)

Primary DI
05055273201949
Brand
COPPER (Cu)
Company
RANDOX LABORATORIES LIMITED
Model
CU2340
Published
2019-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JKZDiethyldithiocarbamate (Colorimetric), Copper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKZDiethyldithiocarbamate (Colorimetric), CopperClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273201949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273201949050552732019495055273201949

GMDN Terms#

Term, Definition table
TermDefinition
Copper IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of copper (Cu) in a clinical specimen, using a spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
227530649
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971674865834BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22
06971674865841BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22
06971674865858BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22
06971674865865BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22
06971674865872BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22
06971674865889BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22
06971674865896BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22
06971674865902BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22
06971674865919BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22
06971674865926BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22
06971674865933BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22
06971674865940BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JKZ2023-07-22