AccessGUDID - DEVICE: NMR Reference Standard (B3959930030)

GUDID

Device Identifier (DI) Information

Brand Name: NMR Reference Standard
Version or Model: 9930030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9930030
Company Name: Labcorp of America

Primary DI Number: B3959930030
Issuing Agency: HIBCC
Commercial Distribution End Date: September 19, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 012822243 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57877	Lipid profile analyser IVD, laboratory, automated	A 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product 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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ded41bd6-b536-42dc-9119-3ce16c99f894
Public Version Date: September 25, 2019
Public Version Number: 4
DI Record Publish Date: April 18, 2017