FDA.reportPublic FDA data

VITROS

Primary DI
10758750004720
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
8318925
Catalog number
8318925
Device description
VITROS Chemistry Products Li Slides
Published
2016-08-26
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
JIHFLAME PHOTOMETRY, LITHIUM

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750004727PackageGS130In Commercial Distribution
10758750004720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000472720758750004727
1075875000472010758750004720

GMDN Terms#

Term, Definition table
TermDefinition
Lithium therapeutic drug monitoring IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the central nervous system drug lithium in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius-18 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623873044
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750000340VITROS194392719439272020-05-16
10758750012824ORTHO690457769045762017-03-23
10758750012817ORTHO690457769045772016-08-24
10758750003020BIOCLONE7112207112202014-10-22
10758750003075BIOCLONE7113207113202014-10-22
10758750003129BIOCLONE7115207115202014-10-22
10758750003198BIOCLONE7130807130802014-10-22
10758750003259BIOCLONE7131807131802014-10-22
10758750003266BIOCLONE7140807140802014-10-22
10758750003297BIOCLONE7141807141802014-10-22
10758750003389BIOCLONE7152807152802014-10-22
10758750003662BIOCLONE7173807173802014-10-22
10758750003822ORTHO7190007190002014-10-22
10758750003839SURGISCREEN7191007191002014-10-22
10758750003877AFFIRMAGEN7192017192012014-10-22
10758750003907AFFIRMAGEN7192107192102014-10-22
10758750003914AFFIRMAGEN7192117192112014-10-22
10758750003952ORTHO7193107193102014-10-22
10758750003976RESOLVE7194107194102014-10-22
10758750003990RESOLVE7195107195102014-10-22

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
04015630028795Roche 9180 Lithium ElectrodeRoche Diagnostics GmbHJIH2016-09-20
10758750009466VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JIH2016-08-26