Duns Number:540156544
Device Description: For the quantitative determination of galactose and galactose-1-phosphate in dried blood. For the quantitative determination of galactose and galactose-1-phosphate in dried blood. Note: Kit contains multiple packages.
Catalog Number
3029-0010
Brand Name
Neonatal Total Galactose kit
Version/Model Number
3029-0010
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
K071649
Product Code
JIA
Product Code Name
Enzymatic Methods, Galactose
Public Device Record Key
239e4cd5-07d9-47f1-aebd-4018aedb61ad
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 02, 2017
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 |