FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674866664
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:60mL×2 R2:20mL×2
Published
2023-07-22
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
MSJApolipoproteins

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSJApolipoproteinsClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971674866664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674866664069716748666646971674866664

GMDN Terms#

Term, Definition table
TermDefinition
Apolipoprotein E (Apo E) 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 apolipoprotein E (Apo E) lipid 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
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
06936895301882BIOBASER1:64mL×2 R2:16mL×22023-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817089022478DiazymeDIAZYME LABORATORIES, INC.MSJ2026-01-21
06971674866671BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-22
06971674866688BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-22
06971674867920BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-22
06971674868255BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-22
06971674860778BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860785BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860792BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860808BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860815BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860822BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860839BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860846BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860853BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860860BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860877BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860884BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860891BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860907BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860914BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860921BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860938BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860945BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860952BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860969BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860976BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860983BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860990BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674861003BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674861010BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20