Duns Number:342920388
Device Description: REA263 recognizes the CD13 antigen, a 150–170 kDa type II transmembrane glycoprotein, whic REA263 recognizes the CD13 antigen, a 150–170 kDa type II transmembrane glycoprotein, which is also known as aminopeptidase N or gp150. CD13 is expressed on granulocytes, myeloid progenitors, endothelial cells, epithelial cells, and subset of granular lymphoid cells. It is also broadly expressed in other tissues such as kidney proximal tubules, intestine, and placenta. CD13 is an enzyme that is used as a biomarker to detect damage to the kidneys, and that may be used to help diagnose certain kidney disorders. It also serves as a receptor for one strain of human coronavirus that is an important cause of upper respiratory tract infections. Defects in CD13 appear to be a cause of various types of leukemia or lymphoma. Additional information: Clone REA263 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD13-PE
Version/Model Number
170-081-019
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
a0c2f072-99ff-478d-ab04-6f056b4e7f2b
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 |