Duns Number:276801933
Device Description: Device designed for the qualitative detection and the characterization of monoclonal prote Device designed for the qualitative detection and the characterization of monoclonal proteins by capillary electrophoresis
Catalog Number
2600
Brand Name
CAPI 3 IMMUNOTYPING
Version/Model Number
2600
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
K161928
Product Code
CEF
Product Code Name
Electrophoretic, Protein Fractionation
Public Device Record Key
859e33e9-3132-432e-8238-2a042764833f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 24, 2018
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |