Duns Number:045623154
Device Description: Pointe Alkaline Phosphatase packaged for the BS480 Analyzer. 3x60mL, 3x15mL kit. For the Pointe Alkaline Phosphatase packaged for the BS480 Analyzer. 3x60mL, 3x15mL kit. For the quantitative determination of alkaline phosphatase in human serum on the BS480 Analyzer.. For in vitro diagnostic use only.
Catalog Number
14-A7516-225
Brand Name
Pointe Alkaline Phosphatase on the BS480
Version/Model Number
14-A7516-225
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
K973588
Product Code
CJE
Product Code Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Public Device Record Key
207d2be5-2988-4a2e-b4a6-7324f7e8d718
Public Version Date
June 05, 2020
Public Version Number
1
DI Record Publish Date
May 28, 2020
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |