FDA.report

BIOBASE

Primary DI
06971674860044
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R:20mL×2
Published
2023-07-08
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

Related Records

Product Codes

CodeName
CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol

Product Code Classifications

CodeDeviceSpecialtyClass
CGOLieberman-Burchard/Abell-Kendall, Colorimetric, CholesterolClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06971674860044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06971674860044069716748600446971674860044

GMDN Terms

TermDefinition
Total cholesterol lipid 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 total cholesterol lipid in a clinical specimen.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
06971674860013BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860020BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860037BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860051BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860068BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860075BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860082BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860099BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860105BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860112BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860129BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860136BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860143BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860150BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860167BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860174BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860181BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08
06971674860198BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CGO2023-07-08