Duns Number:540156544
Device Description: For the quantitative determination of phenylalanine in dried blood.
Catalog Number
NP-4000
Brand Name
Neonatal Phenylalanine kit
Version/Model Number
NP-4000
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
K943547
Product Code
JNB
Product Code Name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Public Device Record Key
c58848e4-8625-463e-a948-5ad7d0374520
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 02, 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 |