Duns Number:072915986
Device Description: Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the c Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection,stabilization, and transport of venous whole blood samples for use in conjunction with cell-free DNAnext- generation sequencing liquid biopsy assays that have been cleared or approved for use with samplescollected in the Cell-Free DNA BCT device.
Catalog Number
230470
Brand Name
Cell-Free DNA BCT
Version/Model Number
230470
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN200001,DEN200001
Product Code
QMA
Product Code Name
Blood Collection Device For Cell-Free Nucleic Acid
Public Device Record Key
936b62ec-fa23-4463-8bc9-26f3e8f5b82d
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
August 10, 2020
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 |