FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674861768
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:48mL×2 R2:16mL×2
Published
2023-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JPZColorimetric Method, Gamma-Glutamyl Transpeptidase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPZColorimetric Method, Gamma-Glutamyl TranspeptidaseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971674861768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674861768069716748617686971674861768

GMDN Terms#

Term, Definition table
TermDefinition
Gamma-glutamyltransferase (GGT) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of gamma glutamyltransferase (GGT) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420046355
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971674866664BIOBASER1:60mL×2 R2:20mL×22023-07-22
06971674866671BIOBASER1:18mL×4 R2:6mL×42023-07-22
06971674866688BIOBASER1:18mL×1 R2:6mL×12023-07-22
06971674867920BIOBASECalibrator: 1mL×12023-07-22
06971674868255BIOBASEControl: 1mL×12023-07-22
06971674866190BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866206BIOBASER1:40mL×2 R2:20mL×22023-07-22
06971674866213BIOBASER1:20mL×4 R2:10mL×42023-07-22
06971674866220BIOBASER1:20mL×1 R2:10mL×12023-07-22
06971674866237BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866244BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866251BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674868231BIOBASEControl:1mL×12023-07-22
06971674867272BIOBASER1:60mL×2 R2:20mL×22023-07-24
06971674867289BIOBASER1:18mL×4 R2:6mL×42023-07-24
06971674867296BIOBASER1:18mL×1 R2:6mL×12023-07-24
06971674867302BIOBASER1:48mL×2 R2:16mL×22023-07-24
06971674867319BIOBASER1:90mL×1 R2:30mL×12023-07-24
06971674867326BIOBASER1:48mL×2 R2:16mL×22023-07-24
06971674867777BIOBASECalibrator:1mL×12023-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971674861676BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861683BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861713BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861720BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861737BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861744BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861799BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861805BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861812BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861829BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861836BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861843BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861690BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861706BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861751BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861775BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861782BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
05055273203462GAMMA-GLUTAMYLTRANSERASE (GGT)RANDOX LABORATORIES LIMITEDJPZ2022-09-22
05055273208801GAMMA-GLUTAMYLTRANSERASE (GGT)RANDOX LABORATORIES LIMITEDJPZ2022-09-22
05055273215502GAMMA-GLUTAMYLTRANSERASE (GGT)RANDOX LABORATORIES LIMITEDJPZ2022-09-22
00817302024159CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209CAROLINA LIQUID CHEMISTRIES CORPORATIONJPZ2022-08-19
00817302024395CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT DT209CAROLINA LIQUID CHEMISTRIES CORPORATIONJPZ2022-08-19
00817302024531CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT ST209CAROLINA LIQUID CHEMISTRIES CORPORATIONJPZ2022-08-19
00380740155308AlinityABBOTT IRELANDJPZ2022-06-14
00380740155315AlinityABBOTT IRELANDJPZ2022-06-14
00380740155896ARCHITECTABBOTT IRELANDJPZ2022-06-14
00380740155902ARCHITECTABBOTT IRELANDJPZ2022-06-14
00380740161712ARCHITECTAbbott GmbHJPZ2020-02-29
00380740161729ARCHITECTAbbott GmbHJPZ2020-02-29
05055273203455GGTRANDOX LABORATORIES LIMITEDJPZ2018-12-24