FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674860983
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:60mL×1 R2:20mL×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
MSJApolipoproteins

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSJApolipoproteinsClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971674860983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674860983069716748609836971674860983

GMDN Terms#

Term, Definition table
TermDefinition
Apolipoprotein B (Apo B) 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 B (Apo B) lipid 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
06971674866664BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-22
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
06971674860990BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674861003BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674861010BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674861027BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20