Duns Number:072915986
Device Description: A direct-draw blood collection tube for the preservation of whole blood specimens for immu A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 5 ml vials.
Catalog Number
213362
Brand Name
Cyto-Chex BCT
Version/Model Number
213362
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080552,K080552
Product Code
GIM
Product Code Name
Tubes, Vacuum Sample, With Anticoagulant
Public Device Record Key
a3b1d4fb-54ef-4377-b9ba-5a4f5828ba72
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 |