FDA.reportPublic FDA data

Reference Electrode

Primary DI
04987762129841
Brand
Reference Electrode
Company
JEOL LTD.
Model
781611407
Published
2020-09-15
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
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
JJPElectrode, Ion Selective (Non-Specified)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1
JJPElectrode, Ion Selective (Non-Specified)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987762129841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987762129841049877621298414987762129841

GMDN Terms#

Term, Definition table
TermDefinition
Reference electrode IVDAn electrochemical sensor intended to be used as a known reference for electrical potential in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690565023
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987762129759ISE Buffer (IS)7816113342020-10-09
04987762129766Reagent Probe Wash S7816114822020-09-15
04987762129773Reagent Probe Wash K7816114742020-09-15
04987762129780Reagent Probe Wash 27816114662020-09-15
04987762129797Reagent Probe Wash 17816114582020-09-15
04987762129810Cuvette Conditioner EX7816114312020-09-15
04987762129827Cuvette Wash Solution 77816114232020-09-15
04987762129834ISE Detergent Solution7816114152020-09-15
04987762129889ISE Serum Standard Set NA7816113512020-09-15
04987762129896Internal Standard7816113422020-09-15
04987762129902ISE Urine Standard Set7816113692020-09-15
04987762129803Lamp Coolant C7816114402020-09-15
04987762129858Chloride Electrode7816113932020-09-15
04987762129865Potassium Electrode7816113852020-09-15
04987762129872Sodium Electrode7816113772020-09-15

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