Duns Number:071245690
Device Description: Cell suspension containing fixed human lymphoblastoid REH (TdT+) and RA-1 (TdT-) cells50% Cell suspension containing fixed human lymphoblastoid REH (TdT+) and RA-1 (TdT-) cells50% TdT+ and 50% TdT- cells at a concentration of 2 x 10^7 cells/mL1.0 mL bottle for approximately 20 tests
Catalog Number
9500
Brand Name
TdT Control Cell Suspension
Version/Model Number
9500A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
KIR
Product Code Name
Cells, Animal And Human, Cultured
Public Device Record Key
4e9f780d-d458-454c-a8bc-7735be7dd124
Public Version Date
November 27, 2019
Public Version Number
2
DI Record Publish Date
October 08, 2019
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 | 7 |