FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge PCHE

Primary DI
00842768015373
Brand
Dimension Vista® Flex® reagent cartridge PCHE
Company
Siemens Healthcare Diagnostics Inc.
Model
10445156
Catalog number
K3051
Device description
Pseudocholinesterase Flex® reagent cartridge, 160 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
DIHColorimetry, cholinesterase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIHColorimetry, CholinesteraseClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061655000DIMENSION VISTA FLEX REAGENT CARTRIDGESDade Behring, Inc.2006-07-10LDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015373PrimaryGS10
00630414005195Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015373008427680153738427680153730842768015373
00630414005195006304140051956304140051950630414005195

GMDN Terms#

Term, Definition table
TermDefinition
Pseudocholinesterase IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of the enzyme pseudocholinesterase in a clinical specimen, using an enzyme spectrophotoometry 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
00860010612200Test-mate ChE Cholinesterase Test SystemEqm Research, Inc.DIH2023-07-31
00860010612217AChE Assay KitEqm Research, Inc.DIH2023-07-31
00860010612224PChE Assay KitEqm Research, Inc.DIH2023-07-31
10673486001488Teco Diagnostics Cholinesterase Reagent SetTECO DIAGNOSTICSDIH2023-07-26
06971674862932BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862949BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862956BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862963BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862970BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862987BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862994BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863007BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863014BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863021BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863038BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863045BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863052BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
00630414611044Atellica CH Cholinesterase_2Siemens Healthcare Diagnostics Inc.DIH2023-06-29
00630414305042Atellica CH Cholinesterase_2Siemens Healthcare Diagnostics Inc.DIH2023-06-29
08800055732985ARENA StarARUM DENTISTRY Co., Ltd.DIH2023-03-31
04015630991549CholinesteraseRoche Diagnostics GmbHDIH2021-06-28
04015630920945Cholinesterase Gen.2Roche Diagnostics GmbHDIH2021-01-18
00630414465401ADVIA® Chemistry CHE Cholinesterase ReagentsSiemens Healthcare Diagnostics Inc.DIH2020-09-24
00630414510149ADVIA® Chemistry CHE Cholinesterase ReagentsSiemens Healthcare Diagnostics Inc.DIH2020-09-24
00630414596273Atellica CH CHESiemens Healthcare Diagnostics Inc.DIH2020-09-24
00842768014178Dimension® Flex® reagent cartridge PCHESiemens Healthcare Diagnostics Inc.DIH2020-09-24
10758750000241VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DIH2020-04-18
10758750004225VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DIH2020-04-18
07613336133620Cholinesterase Gen.2Roche Diagnostics GmbHDIH2020-03-05
05055273201093BUTYRYL CHOLINESTERASE (CHE)RANDOX LABORATORIES LIMITEDDIH2019-06-03