FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge AMM

Primary DI
00630414948102
Brand
Dimension Vista® Flex® reagent cartridge AMM
Company
Siemens Healthcare Diagnostics Inc.
Model
10711992
Catalog number
K3119
Device description
Ammonia Flex® reagent cartridge, 120 tests
Published
2020-09-24
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
JIFENZYMATIC METHOD, AMMONIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIFEnzymatic Method, AmmoniaClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123677000DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)Siemens Healthcare Diagnostics2013-03-07JIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414948102PrimaryGS10
00630414006093Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414948102006304149481026304149481020630414948102
00630414006093006304140060936304140060930630414006093

GMDN Terms#

Term, Definition table
TermDefinition
Ammonia IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ammonia in a clinical specimen, using an enzyme 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
00845275000016Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers Fisher DiagnosticsJIF2025-11-18
08058056680181Ammonia Ultra SENTINEL CH. SPAJIF2023-11-22
04015630914708AmmoniaRoche Diagnostics GmbHJIF2021-02-08
04015630927005AmmoniaRoche Diagnostics GmbHJIF2021-02-08
04015630928071AmmoniaRoche Diagnostics GmbHJIF2021-02-08
00630414555898ADVIA® Chemistry AMM Ammonia ReagentsSiemens Healthcare Diagnostics Inc.JIF2020-09-24
00630414595832Atellica CH AmmSiemens Healthcare Diagnostics Inc.JIF2020-09-24
00630414948096Dimension® Flex® reagent cartridge AMMSiemens Healthcare Diagnostics Inc.JIF2020-09-24
07613336121429Ammonia IIRoche Diagnostics GmbHJIF2020-03-05
05055273200256AMMONIA (NH3)RANDOX LABORATORIES LIMITEDJIF2019-06-04
05055273200263AMMONIA (NH3)RANDOX LABORATORIES LIMITEDJIF2019-06-04
04015630936533Ammonia IIRoche Diagnostics GmbHJIF2019-05-10
04015630936526Ammonia IIRoche Diagnostics GmbHJIF2019-03-26
05055273200270NH3RANDOX LABORATORIES LIMITEDJIF2018-12-24
00817238011247Ammonia StandardCLINIQA CORPORATIONJIF2018-08-23
00817238011438Ammonia ReagentCLINIQA CORPORATIONJIF2018-08-23
00380740010768ARCHITECTABBOTT LABORATORIESJIF2018-07-31
00380740010775ARCHITECTABBOTT LABORATORIESJIF2018-07-31
00380740136192AlinityABBOTT LABORATORIESJIF2018-07-30
00845275005400Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON SystemsFisher DiagnosticsJIF2016-09-16
00628063400010Ammonia L3KSekisui Diagnostics, LLCJIF2016-09-16
00811727010247POINTE SCIENTIFIC AMMONIAHORIBA INSTRUMENTS INCORPORATEDJIF2016-08-31
00811727010254POINTE SCIENTIFIC AMMONIAHORIBA INSTRUMENTS INCORPORATEDJIF2016-08-31
00811727010261POINTE SCIENTIFIC Ammonia Standard 1HORIBA INSTRUMENTS INCORPORATEDJIF2016-08-31
00811727010278POINTE SCIENTIFIC Ammonia Standard 5HORIBA INSTRUMENTS INCORPORATEDJIF2016-08-31
15099590222635SynchronBeckman Coulter, Inc.JIF2016-08-24