Duns Number:342920388
Device Description: A3C6E2 recognizes human CD117, also known as c-kit or SCF receptor. It is a 145 kDa recept A3C6E2 recognizes human CD117, also known as c-kit or SCF receptor. It is a 145 kDa receptor tyrosine kinase that is involved in stem cell signaling, activation, and proliferation. The CD117 antigen is expressed on about 1–3% of mononuclear cells from peripheral blood mononuclear cells (PBMCs) or cord blood, and on up to 10% of bone marrow cells. CD117 is further expressed on basophils, myeloid dendritic cells, TCRa/b+ T cells, CD19+ B cells, and CD56+ NK cells, as well as on mast cells, melanocytes, and AML (acute myeloid leukemia) blasts.
Catalog Number
-
Brand Name
CD117-APC
Version/Model Number
170-081-016
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
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
27d90d10-c45d-466a-853c-1749d98120e8
Public Version Date
April 05, 2021
Public Version Number
1
DI Record Publish Date
March 26, 2021
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 | 88 |