FDA.reportPublic FDA data

Lithium Electrode

Primary DI
00811403010691
Brand
Lithium Electrode
Company
Diamond Diagnostics Inc.
Model
AV-BP0962D
Device description
Measuring concentration of Lithium (from drug Lithium carbonate) in whole blood, serum, and plasma samples.
Published
2023-06-05
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
true

Product Codes#

Code, Name table
CodeName
NDWAssay, Porphyrin, Spectrophotometry, Lithium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDWAssay, Porphyrin, Spectrophotometry, LithiumClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811403010691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811403010691008114030106918114030106910811403010691

GMDN Terms#

Term, Definition table
TermDefinition
Lithium electrode IVDAn electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of lithium ions in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
947514303
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811403010158Photometer LampOY-MU8550D2023-06-13
00811403010240Reference SolutionIL-09756904D2023-06-13
00811403013074Pump Tubing KitCD-105673D2023-06-13
00811403013173C1/C2 Cleaning SolutionCD-473389D2023-06-13
00811403010387Wash PackCD-473497D2023-06-13
00811403013296pH ElectrodeCD-476267D2023-06-13
00811403013302Calcium ElectrodeCD-476268D2023-06-13
00811403013319Potassium ElectrodeCD-476270D2023-06-13
00811403013326Reference ElectrodeCD-476273D2023-06-13
00811403013333Chloride ElectrodeCD-476279D2023-06-13
00811403013371Fill SolutionCD-478533D2023-06-13
00811403013388Na-K-Ca-Cl Fill SolutionCD-478535D2023-06-13
00811403013456Conditoner SolutionCD-478701D2023-06-13
00811403013463Reference SolutionCD-478822D2023-06-13
00811403013609Printer PaperCD-67252D2023-06-13
00811403013630Pump TubingCD-673705D2023-06-13
00811403014040Salt Bridge SolutionDA-D105D2023-06-13
00811403014217Quick IMT Sample DiluentDA-S635D2023-06-13
00811403014224Quick IMT Diluent CheckDA-S640D2023-06-13
00811403015504Maintenance KitHM-XEA328ASD2023-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414287935Atellica CH Lithium_2 (LITH_2)Siemens Healthcare Diagnostics Inc.NDW2020-11-27
00630414288178ADVIA Chemistry Lithium_2 (LITH_2) reagentsSiemens Healthcare Diagnostics Inc.NDW2020-11-27
07613336121382LithiumRoche Diagnostics GmbHNDW2020-03-05
00380740136277AlinityABBOTT LABORATORIESNDW2018-07-30
00630414006789Atellica CH LiSiemens Healthcare Diagnostics Inc.NDW2017-12-21
00842768035326Dimension Vista® Flex® reagent cartridge LITHSiemens Healthcare Diagnostics Inc.NDW2016-09-24
00630414509778ADVIA® Chemistry LITH Lithium ReagentsSiemens Healthcare Diagnostics Inc.NDW2016-09-24
04015630032440Lithium ElectrodeRoche Diagnostics GmbHNDW2016-09-20
00385480132039NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480139847NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480140829NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480141871NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
10385480152126NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
10385480157428NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
05055273209143Li 2RANDOX LABORATORIES LIMITEDNDW2016-09-16
00845275000429Thermo Scientific Infinity™Fisher DiagnosticsNDW2016-09-16
00845275003345Thermo Scientific Infinity™ for Olympus AnalyzersFisher DiagnosticsNDW2016-09-16
00845275003352Thermo Scientific Infinity™Fisher DiagnosticsNDW2016-09-16
00845275004526Thermo Scientific Infinity™ for Beckman Coulter AU® Chemistry AnalyzersFisher DiagnosticsNDW2016-09-16
00845275005417Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON SystemsFisher DiagnosticsNDW2016-09-16
00845275005424Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON SystemsFisher DiagnosticsNDW2016-09-16
00385480131971NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-16
00385480131988NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-16
00380740017712ARCHITECTABBOTT LABORATORIESNDW2016-09-09