Duns Number:540156544
Device Description: For the quantitative measurement of the activity of certain lysosomal enzymes in dried blo For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots.Note: Kit contains multiple packages.
Catalog Number
3093-001U
Brand Name
NeoLSD MSMS kit
Version/Model Number
3093-001U
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
-
Product Code
PQW
Product Code Name
Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
Public Device Record Key
9d1db15b-2b28-4d7f-a251-8b7d77bba1f6
Public Version Date
February 15, 2022
Public Version Number
2
DI Record Publish Date
November 28, 2018
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 |