Duns Number:429572365
Device Description: The kit is intended for the quantitative determination of ceruloplasmin (CER) in serum and The kit is intended for the quantitative determination of ceruloplasmin (CER) in serum and plasma by immunoturbidimetry. For in vitro diagnostic use only.
Catalog Number
A26842
Brand Name
Ceruloplasmin
Version/Model Number
A26842
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
K051456
Product Code
JFR
Product Code Name
Indirect Copper Assay, Ceruloplasmin
Public Device Record Key
02d12436-ba30-48b1-bf1a-afdb645e3743
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 29, 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |