FDA.reportPublic FDA data

Roche 9180 Electrolyte Analyzer

Primary DI
04015630031832
Brand
Roche 9180 Electrolyte Analyzer
Company
Roche Diagnostics GmbH
Model
3157334001
Catalog number
3157334001
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JFPELECTRODE, ION SPECIFIC, CALCIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFPElectrode, Ion Specific, CalciumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630031832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630031832040156300318324015630031832

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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