Duns Number:137825928
Device Description: ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots.
Catalog Number
07575305
Brand Name
Neonatal Phenylalanine ELISA Kit (without membrane)
Version/Model Number
07575305
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K926106
Product Code
JNB
Product Code Name
NINHYDRIN AND L-LEUCYL-L-ALANINE (FLUORIMETRIC), PHENYLALANINE
Public Device Record Key
eaa6a073-b25c-4b08-a130-7df708646782
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 20, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 36 |