Duns Number:540156544
Device Description: This reagent package is intended for sample processing in the assay of in vitro measuremen This reagent package is intended for sample processing in the assay of in vitro measurement and evaluation of the concentrations of amino acids, succinylacetone and acylcarnitines in dried blood spot samples (DBS) on filter paper.This reagent package is used together with the NeoBase Non-derivatized MSMS Kit and the NeoBase Succinylacetone Assay Solution.
Catalog Number
3041-0020
Brand Name
NeoBase Non-derivatized Assay Solutions
Version/Model Number
3041-0020
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
aeac7032-350b-42f3-b05b-e343587c5397
Public Version Date
December 13, 2018
Public Version Number
5
DI Record Publish Date
February 11, 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 |