Duns Number:342920388
Device Description: REA196 recognizes the human CD56 antigen, a glycoprotein of the Ig-superfamily, also known REA196 recognizes the human CD56 antigen, a glycoprotein of the Ig-superfamily, also known as neural cell adhesion molecule (NCAM), which is expressed in blood on practically all resting and activated NK cells and on a minor subset of CD3+ T cells. CD56 is also expressed in brain (cerebellum and cortex) and at neuromuscular junctions. Certain large granular lymphocyte (LGL) leukemias, small-cell lung carcinomas, neuronal-derived tumors, myelomas, and myeloid leukemias also express CD56. Additional information: Clone REA196 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD56-PE
Version/Model Number
170-081-014
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
06ab0fde-e44c-4971-9341-7445b828b8f9
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 |