CD13-PE - REA263 recognizes the CD13 antigen, a 150–170 kDa - Miltenyi Biotec B.V. & Co. KG

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.

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More Product Details

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

Product Characteristics

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"

-

For Single-Use

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Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MVU

Product Code Name

Reagents, Specific, Analyte

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MILTENYI BIOTEC B.V. & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 88