FDA.reportPublic FDA data

NMR WASH Solution

Primary DI
B3959910030
Brand
NMR WASH Solution
Company
Labcorp of America
Model
9910030
Catalog number
9910030
Device description
WASH Solution used for the Vantera 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
B3959910030PrimaryHIBCC0

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3959900300Vantera Clinical Analyzer990030099003002016-11-11
B3959920030NMR Diluent 1992003099200302017-04-18
B3959930030NMR Reference Standard993003099300302017-04-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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15420045517066Aptima®Hologic, Inc.NSU2024-12-19
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15420045517080Aptima®Hologic, Inc.NSU2024-12-19
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06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.MRR2024-07-12
00850053916250IDG/SanzayIDG/SANZAY CorporationLBS2024-06-25
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00840487101964LIAISON PLEX® Chassis (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00840487101971LIAISON PLEX® ModuleLUMINEX CORPORATIONNSU2024-06-20
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00875197006926cobas Buffer Negative Control KitRoche Diagnostics GmbHNSU2024-06-05
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