FDA UDI Not in Commercial Distribution 🇺🇸 United States

Vantera Clinical Analyzer

DI: B3959900300 · Model: 9900300 · Labcorp of America
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Vantera Clinical Analyzer
Primary DI
B3959900300
Version / Model
9900300
Catalog Number
9900300
Company Name
Labcorp of America
Labeler DUNS
012822243
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-11-11
Public Version
4
Public Version Date
2019-09-25
Public Version Status
Update
Public Device Record Key
87ac9701-4d6e-4d6b-95dd-5880b0cc7a59
Distribution End Date
2019-09-19

Device Description

Clinical Analyzer

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

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

GMDN Terms

Code Name
57877 Lipid profile analyser IVD, laboratory, automated

Identifiers

Type ID
Primary B3959900300