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Vantera Clinical Analyzer

Primary DI
B3959900300
Brand
Vantera Clinical Analyzer
Company
Labcorp of America
Model
9900300
Catalog number
9900300
Device description
Clinical Analyzer
Published
2016-11-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
MRRSystem, Test, Low Density, Lipoprotein
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesClinical Chemistry1
LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlClinical Chemistry1
MRRSystem, Test, Low Density, LipoproteinClinical Chemistry1
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113830000VANTERA CLINICAL ANALYZERLiposcience2012-08-30CDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3959900300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Lipid profile analyser IVD, laboratory, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of lipid profile analytes (cholesterol, fatty acids, lipids, lipoproteins and/or triglycerides) in a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
919-256-1157bakers9@labcorp.com

Regulatory Flags#

DUNS number
012822243
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3959910030NMR WASH Solution991003099100302016-11-11
B3959920030NMR Diluent 1992003099200302017-04-18
B3959930030NMR Reference Standard993003099300302017-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613336206362cobas® 8800 systemRoche Molecular Systems, Inc.NSU2026-03-26
04049016126034EUROArrayScanEUROIMMUN Medizinische Labordiagnostika AGNSU2025-12-19
00851458005327SPOTFIRE Control Station - ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
00851458005334SPOTFIRE Control Station - non-ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
05060441760005binx ioBINX HEALTH LIMITEDNSU2025-09-03
10190302019897Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
10190302019903Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
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04719880531103QLociLIFEOS GENOMICS CORPORATIONNSU2025-04-30
00850063063005DASH® Rapid PCR InstrumentNuclein, LLCNSU2025-01-06
00856826006203Applied BiosystemsAffymetrix, Inc.NSU2024-12-24
15420045517059Aptima®Hologic, Inc.NSU2024-12-19
15420045517066Aptima®Hologic, Inc.NSU2024-12-19
15420045517073Aptima®Hologic, Inc.NSU2024-12-19
15420045517080Aptima®Hologic, Inc.NSU2024-12-19
06974849369403EudemonTM AIO800Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NSU2024-11-14
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCNSU2024-07-26
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.MRR2024-07-12
00850053916250IDG/SanzayIDG/SANZAY CorporationLBS2024-06-25
00840487101957LIAISON PLEX® ChassisLUMINEX CORPORATIONNSU2024-06-20
00840487101964LIAISON PLEX® Chassis (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00840487101971LIAISON PLEX® ModuleLUMINEX CORPORATIONNSU2024-06-20
00840487101988LIAISON PLEX® Module (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00875197006926cobas Buffer Negative Control KitRoche Diagnostics GmbHNSU2024-06-05
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCNSU2024-05-03