Duns Number:342920388
Device Description: The monoclonal antibody UP-H2 reacts with human CD300e, also known as IREM-2, LMIR6, or CM The monoclonal antibody UP-H2 reacts with human CD300e, also known as IREM-2, LMIR6, or CMRF35-A5. This 34 kDa activating receptor of the immunoglobulin superfamily is expressed on mature myeloid dendritic cells and monocytes and is down-regulated on immature dendritic cells. CD300e interacts with DAP-12, which mediates activating signals. It is reported that the alloreactive response of naive T cells is enhanced by IREM-2 activation of mDCs.
Catalog Number
-
Brand Name
CD300e-APC
Version/Model Number
170-081-053
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
e73ffae7-bf5c-4bc4-a828-d75e72022087
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 |