FDA.report

Roche 9180 Calcium electrode

Primary DI
04015630028696
Brand
Roche 9180 Calcium electrode
Company
Roche Diagnostics GmbH
Model
03110354180
Catalog number
03110354180
Published
2021-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JFPElectrode, ion specific, calcium

Product Code Classifications

CodeDeviceSpecialtyClass
JFPElectrode, Ion Specific, CalciumClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04015630028696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04015630028696040156300286964015630028696

GMDN Terms

TermDefinition
Calcium (Ca2+) IVD, kit, ion-selective electrode (ISE)A collection of reagents and other associated materials intended to be used for the quantitative measurement of calcium (Ca2+) in a clinical specimen, using an ion-selective electrode (ISE) method.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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