Duns Number:342920388
Device Description: AC104.3E3 recognizes the human CD33 antigen, a 67 kDa glycoprotein belonging to the sialoa AC104.3E3 recognizes the human CD33 antigen, a 67 kDa glycoprotein belonging to the sialoadhesin superfamily. The CD33 antigen is highly expressed on human monocytes but weakly on granulocytes and some - but not all - myeloid dendritic cells. The CD33 antigen is also found on myeloid progenitor cells (CFU-GEMM, CFU GM, CFU-G, BFU-E) but is not expressed on lymphocytes, platelets, erythrocytes, or primitive hematopoietic stem cells.
Catalog Number
-
Brand Name
CD33-PE
Version/Model Number
170-081-001
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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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
3d99c78c-3a4f-404f-b6f3-28a366cd1ef1
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 |