FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674861751
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:90mL×1 R2:30mL×1
Published
2023-07-20
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
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
06971674861751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674861751069716748617516971674861751

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
06936895301882BIOBASER1:64mL×2 R2:16mL×22023-07-26
06936895301899BIOBASER1:20mL×1 R2:5mL×12023-07-26
06936895301905BIOBASER1:20mL×4 R2:5mL×42023-07-26
06936895301912BIOBASER1:60mL×5 R2:15mL×52023-07-26
06936895301929BIOBASER1:64mL×2 R2:16mL×22023-07-26
06936895301936BIOBASER1:20mL×1 R2:5mL×12023-07-26
06936895301943BIOBASER1:20mL×4 R2:5mL×42023-07-26
06936895301950BIOBASER1:60mL×5 R2:15mL×52023-07-26
06971674862932BIOBASER1:70mL×2 R2:14mL×22023-07-24
06971674862949BIOBASER1:60mL×2 R2:12mL×22023-07-24
06971674862956BIOBASER1:25mL×4 R2:5mL×42023-07-24
06971674862963BIOBASER1:25mL×1 R2:5mL×12023-07-24
06971674862970BIOBASER1:40mL×4 R2:16mL×22023-07-24
06971674862987BIOBASER1:50mL×2 R2:10mL×22023-07-24
06971674862994BIOBASER1:80mL×2 R2:16mL×22023-07-24
06971674863007BIOBASER1:100mL×1 R2:20mL×12023-07-24
06971674863014BIOBASER1:50mL×2 R2:20mL×12023-07-24
06971674863021BIOBASER1:50mL×2 R2:20mL×12023-07-24
06971674863038BIOBASER1:50mL×2 R2:10mL×22023-07-24
06971674863045BIOBASER1:50mL×2 R2:10mL×22023-07-24

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
06971674861768BIOBASEBiobase 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
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 GmbH & Co. KGJPZ2020-02-29
00380740161729ARCHITECTAbbott GmbH & Co. KGJPZ2020-02-29
05055273203455GGTRANDOX LABORATORIES LIMITEDJPZ2018-12-24