FDA.reportPublic FDA data

Roche 9180 Lithium Electrode

Primary DI
04015630028795
Brand
Roche 9180 Lithium Electrode
Company
Roche Diagnostics GmbH
Model
3110664180
Catalog number
3110664180
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JIHFLAME PHOTOMETRY, LITHIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIHFlame Photometry, LithiumClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630028795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630028795040156300287954015630028795

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811403015979Internal Filling Solution Diamond Diagnostics Inc.JIH2023-06-06
00811403010028SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics Inc.JIH2023-06-05
00811403019892SmartLyte Electrolyte AnalyzerDiamond Diagnostics Inc.JIH2023-06-05
00811403019984ProLyte Electrolyte AnalyzerDiamond Diagnostics Inc.JIH2023-06-05
00386100002282ISE Reagent PackMEDICA CORPORATIONJIH2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONJIH2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONJIH2019-02-14
00386100001667ISE Lithium Electrode MEDICA CORPORATIONJIH2018-12-11
00386100002480Lithium Electrode MEDICA CORPORATIONJIH2018-12-11
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONJIH2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONJIH2018-12-11
00386100002886Lithium Na/K/Li AnalyzerMEDICA CORPORATIONJIH2018-12-04
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONJIH2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONJIH2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONJIH2018-12-04
00386100003074Na/K/Li Solution PackMEDICA CORPORATIONJIH2018-12-04
00386100003104Na/K/Li Solution PackMEDICA CORPORATIONJIH2018-12-04
00386100003005Lithium ElectrodeMEDICA CORPORATIONJIH2018-11-08
00842768005367Dimension® Flex® reagent cartridge LISiemens Healthcare Diagnostics Inc.JIH2016-09-24
00630414451824RAPIDChem® 754 Na+K+Li+ Reagent ModuleSiemens Healthcare Diagnostics Inc.JIH2016-09-24
00630414451862RAPIDChem® 700 Lithium SensorSiemens Healthcare Diagnostics Inc.JIH2016-09-24
10758750004720VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JIH2016-08-26
10758750009466VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JIH2016-08-26