FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge LDLC

Primary DI
00842768015267
Brand
Dimension Vista® Flex® reagent cartridge LDLC
Company
Siemens Healthcare Diagnostics Inc.
Model
10445096
Catalog number
K3131
Device description
Low-Density Lipoprotein Cholesterol Flex® reagent cartridge, 180 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
MRRSYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRRSystem, Test, Low Density, LipoproteinClinical Chemistry1

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
00842768015267PrimaryGS10
00630414004716Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015267008427680152678427680152670842768015267
00630414004716006304140047166304140047160630414004716

GMDN Terms#

Term, Definition table
TermDefinition
Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid 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
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.MRR2024-07-12
10673486002010Teco Diagnostics Direct LDL Cholesterol Reagent SetTECO DIAGNOSTICSMRR2023-11-13
06971674860587BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860594BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860600BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860617BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860624BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860631BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860648BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860655BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860662BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860679BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860686BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860693BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860709BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860716BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860723BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860730BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860747BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860754BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860761BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
05055273213966DIRECT LDL-CHOLESTEROL (LDL)RANDOX LABORATORIES LIMITEDMRR2022-10-04
00817302024142CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024227CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024487CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024623CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT ST661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00630414611037Atellica CH LDLCSiemens Healthcare Diagnostics Inc.MRR2022-07-08
00630414305073Atellica CH LDLCSiemens Healthcare Diagnostics Inc.MRR2022-07-08