Duns Number:012822243
Device Description: NMR Reference Standard used for the Vantera Clinical Analyzer.
Catalog Number
9930030
Brand Name
NMR Reference Standard
Version/Model Number
9930030
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 19, 2019
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CDT
Product Code Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |