FDA.reportPublic FDA data

BIOBASE

Primary DI
06936895300274
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
BKE-B
Published
2023-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJPElectrode, Ion Selective (Non-Specified)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJPElectrode, Ion Selective (Non-Specified)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936895300274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936895300274069368953002746936895300274

GMDN Terms#

Term, Definition table
TermDefinition
Ion-selective analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420046355
Device count
1
Premarket exempt
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
06936895300250BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJP2023-07-04
06936895300267BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJP2023-07-04
06936895300281BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJP2023-07-04
06936895301691BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJP2023-07-04
06936895301707BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJP2023-07-04
04987762129841Reference ElectrodeJEOL LTD.JJP2020-09-15
00853366007134PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.JJP2018-01-26
00853366007332PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.JJP2018-01-26
00853366007349PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.JJP2018-01-26
03610230005866ABX PENTRA REFERENCE-EHORIBA ABX SASJJP2016-08-23