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 each of CD4L and Normal level.
Catalog Number
213375
Brand Name
CD-Chex Plus BC
Version/Model Number
213375
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 16, 2022
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
2e8b8113-9a6f-4a5e-92ad-47193df4d39b
Public Version Date
April 27, 2022
Public Version Number
4
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 |