Duns Number:227530649
Device Description: The ALP method used on the Dimension clinical chemistry system is an in vitro diagnostic t The ALP method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
Catalog Number
AP2809
Brand Name
ALP
Version/Model Number
AP2809
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
Yes
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
K923507
Product Code
CJE
Product Code Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Public Device Record Key
9052fb8a-2b79-4917-83a9-8013c08d867e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 09, 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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |