CD38-APC (Clone REA671) - Clone REA671 recognizes the human CD38 antigen, a - Miltenyi Biotec B.V. & Co. KG

Duns Number:342920388

Device Description: Clone REA671 recognizes the human CD38 antigen, a single-chain type II transmembrane glyco Clone REA671 recognizes the human CD38 antigen, a single-chain type II transmembrane glycoprotein with enzymatic activity. It is present on the majority of hematopoietic cells, prevalent during early differentiation and activation processes. Terminally differentiated B cells (plasma cells) express CD38 brightly. Furthermore, CD38 is constitutively expressed in several tissues, for example, brain, muscle, and kidney. CD38, a disease marker for human leukemias and myelomas, plays a role in the pathogenesis and outcome of human immunodeficiency virus infection and chronic lymphocytic leukemia, and controls insulin release and also the development of diabetes. Furthermore, it catalyzes the synthesis and hydrolysis of cyclic ADP-ribose (cADPR) from NAD+ to ADP-ribose which is essential for the regulation of intracellular Ca2+. Additional information: Clone REA671 displays negligible binding to Fc receptors.

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More Product Details

Catalog Number

-

Brand Name

CD38-APC (Clone REA671)

Version/Model Number

170-081-068

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

a5ef5f05-7991-44b1-a79f-f0c89502462a

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