Duns Number:540156544
Device Description: The product is to be used together with the NeoGram Amino Acids and Acylcarnitines Tandem The product is to be used together with the NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry kit, and is intended for the measurement of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper.
Catalog Number
3030-0020
Brand Name
NeoGram Derivatized Assay Solutions
Version/Model Number
3030-0020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 18, 2022
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
DEN040002
Product Code
NQL
Product Code Name
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Public Device Record Key
942d8fcf-a3cc-431c-b8e1-ae801d719cc2
Public Version Date
March 30, 2022
Public Version Number
4
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 |