FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge LITH

Primary DI
00842768035326
Brand
Dimension Vista® Flex® reagent cartridge LITH
Company
Siemens Healthcare Diagnostics Inc.
Model
10635870
Catalog number
K4150
Device description
Lithium Flex® reagent cartridge, 180 tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K112142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112142000DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics2011-11-04NDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768035326PrimaryGS10
00630414005935Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768035326008427680353268427680353260842768035326
00630414005935006304140059356304140059350630414005935

GMDN Terms#

Term, Definition table
TermDefinition
Lithium therapeutic drug monitoring IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug lithium in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

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
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
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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
05055273209143Li 2RANDOX LABORATORIES LIMITEDNDW2016-09-16
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