Labcorp of America

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instrumentation For Clinical Multiplex Test Systems (NSU) (4) Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS) (4) Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (CDT) (4) System, Test, Low Density, Lipoprotein (MRR) (4)

Premarket Exempt

Clear

Vantera Clinical Analyzer - B3959900300 Catalog Number : 9900300

Device Description : Clinical Analyzer

Device Class : 1

Duns Number: 012822243

Premarket Exempt : No

Product Code : LBS, NSU, MRR, CDT

Prescription Use : Yes

Device Count : 1

NMR WASH Solution - B3959910030 Catalog Number : 9910030

Device Description : WASH Solution used for the Vantera Clinical Analyzer

Device Class : 1

Duns Number: 012822243

Premarket Exempt : No

Product Code : NSU, LBS, MRR, CDT

Prescription Use : Yes

Device Count : 1

NMR Diluent 1 - B3959920030 Catalog Number : 9920030

Device Description : Sample Diluent 1 used for the Vantera Clinical Analyzer.

Device Class : 1

Duns Number: 012822243

Premarket Exempt : No

Product Code : NSU, MRR, CDT, LBS

Prescription Use : Yes

Device Count : 1

NMR Reference Standard - B3959930030 Catalog Number : 9930030

Device Description : NMR Reference Standard used for the Vantera Clinical Analyzer.

Device Class : 1

Duns Number: 012822243

Premarket Exempt : No

Product Code : LBS, NSU, MRR, CDT

Prescription Use : No

Device Count : 1

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