Duns Number:342920388
Device Description: M1/70.15.11.5 recognizes the human, mouse, and non-human primate CD11b antigen. CD11b, als M1/70.15.11.5 recognizes the human, mouse, and non-human primate CD11b antigen. CD11b, also known as Mac-1 alpha or integrin alphaM chain, is part of the CD11b/CD18 heterodimer (Mac-1 alpha, Mbeta2 integrin), also known as the C3 complement receptor. It functions as a receptor for complement (C3bi), fibrinogen, or clotting factor X. In humans, CD11b is strongly expressed on myeloid cells and weakly expressed on NK cells and some activated lymphocytes as well as on microglia in the brain. In mice, the CD11b antigen is expressed on monocytes/macrophages and microglia. To a lower extent it is expressed on granulocytes, NK cells, CD5+ B-1 cells, and subsets of dendritic cells.
Catalog Number
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Brand Name
CD11b-APC
Version/Model Number
170-081-018
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)
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Over the Counter (OTC)
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Kit
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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
2add16d1-6342-40e0-a0fe-12f18d2c8e23
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 |