Duns Number:540156544
Device Description: For the quantitative determination of total galactose concentration in dried blood.Note: K For the quantitative determination of total galactose concentration in dried blood.Note: Kit contains multiple packages.
Catalog Number
3309-002U
Brand Name
GSP Neonatal Total Galactose kit
Version/Model Number
3309-002U
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190335
Product Code
JIA
Product Code Name
Enzymatic Methods, Galactose
Public Device Record Key
0ba67f14-b1a3-4784-ac1e-b003aeb99b73
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 04, 2021
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 |