Duns Number:540156544
Device Description: For the quantitative determination of amino acid, acylcarnitine and free carnitine concent For the quantitative determination of amino acid, acylcarnitine and free carnitine concentrations in dried blood.
Catalog Number
3040-001U
Brand Name
NeoBase Non-derivatized MSMS kit
Version/Model Number
3040-001U
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K083130,K093916
Product Code
NQL
Product Code Name
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Public Device Record Key
135a3e31-795f-4575-8c60-12e3d8321372
Public Version Date
December 13, 2018
Public Version Number
5
DI Record Publish Date
January 12, 2016
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 | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| 3 | A medical device with high risk that requires premarket approval | 2 |