FDA.reportPublic FDA data

Li 2

Primary DI
05055273209143
Brand
Li 2
Company
RANDOX LABORATORIES LIMITED
Model
LM4005
Catalog number
LM4005
Device description
The product is intended for the quantitative in vitro determination of Lithium in serum.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050374000ADVIA IMS LITHIUM ASSAYBayer Healthcare, LLC2005-06-15NDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273209143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273209143050552732091435055273209143

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
Special Storage Condition, Specify00Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
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
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811403010691Lithium ElectrodeDiamond Diagnostics Inc.NDW2023-06-05
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
00385480167291NOVANOVA BIOMEDICAL CORPORATIONNDW2017-04-24
00842768035326Dimension Vista® Flex® reagent cartridge LITHSiemens Healthcare Diagnostics Inc.NDW2016-09-24
00630414509778ADVIA® Chemistry LITH Lithium ReagentsSiemens Healthcare Diagnostics Inc.NDW2016-09-24
00385480152112NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480152129NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480157421NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480539630NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480539647NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
04015630921669LithiumRoche Diagnostics GmbHNDW2016-09-20
04015630032440Lithium ElectrodeRoche Diagnostics GmbHNDW2016-09-20
00385480128827NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480131940NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480132039NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480136839NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480139847NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480140829NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480141826NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480141871NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480142441NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
10385480152126NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
10385480157428NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480165013NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00385480167284NOVANOVA BIOMEDICAL CORPORATIONNDW2016-09-20
00845275000429Thermo Scientific Infinity™Fisher DiagnosticsNDW2016-09-16