Duns Number:342920388
Device Description: VIMC6 recognizes the human CD15 antigen which is expressed on human myelomonocytic cells. VIMC6 recognizes the human CD15 antigen which is expressed on human myelomonocytic cells. It is present on neutrophils, eosinophils, and some monocytes, masked on basophils but not on lymphocytes. The antigen is also expressed on Hodgkin/Reed-Sternberg cells. The CD15 antibody recognizes the carbohydrate structure 3-fucosyl-N-acetyl-lactosamine. This structure is also known as stage specific embryonic antigen 1 (SSEA-1) and a common surface marker for pluripotency on mouse ES and iPS cells. On human cells in contrast, SSEA-1 is expressed only on early differentiating cells. The CD15 antibody recognizes the SSEA-1 antigen in both species. For applications in ES and iPS research, the dilution recommended in the data sheet may need adjustment.
Catalog Number
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Brand Name
CD15-FITC
Version/Model Number
170-081-020
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
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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
d3d57c81-01b5-46ba-89d4-07353a44bfec
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 |