Duns Number:276801933
Device Description: Device used for the detection and characterization of monoclonal proteins in human serum a Device used for the detection and characterization of monoclonal proteins in human serum and urine using capillary electrophoresis
Catalog Number
2100
Brand Name
CAPILLARYS IMMUNOTYPING
Version/Model Number
2100
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
-
Product Code
CEF
Product Code Name
Electrophoretic, Protein Fractionation
Public Device Record Key
d62c112d-1cdc-49dc-bfc5-6fce331fd7b0
Public Version Date
March 29, 2018
Public Version Number
2
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 |