Duns Number:540156544
Device Description: For the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains For the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains multiple packages.
Catalog Number
3018-0010
Brand Name
Neonatal Biotinidase kit
Version/Model Number
3018-0010
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090123
Product Code
NAK
Product Code Name
System,Test,Biotinidase
Public Device Record Key
870401a6-f292-4fb6-ae19-c11fc2eeaa7e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 12, 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 |
|---|---|---|
| 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 |