Duns Number:540156544
Device Description: For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration in dried b For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration in dried blood.Note: Kit contains multiple packages.
Catalog Number
3311-001U
Brand Name
GSP Neonatal Creatine Kinase -MM kit
Version/Model Number
3311-001U
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
QJE
Product Code Name
Muscular Dystrophy Newborn Screening Test
Public Device Record Key
ee98419d-ba50-479d-a94d-429b879db213
Public Version Date
February 15, 2022
Public Version Number
2
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 |