Duns Number:072915986
Device Description: A positive procedural control for monitoring immunophenotyping by flow cytometry. Contain A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials of CD4L level.
Catalog Number
213372
Brand Name
CD-Chex Plus BC
Version/Model Number
213372
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051633
Product Code
GGL
Product Code Name
Control, White-Cell
Public Device Record Key
927f07b6-7bf6-43de-8656-ed4934c67555
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 136 |