Duns Number:342920388
Device Description: REA613 recognizes the human CD3 antigen, a single-pass type I membrane protein, also known REA613 recognizes the human CD3 antigen, a single-pass type I membrane protein, also known as Leu4. CD3 is present on mature human T cells, thymocytes, a subset of NK cells, and on Purkinje cells in cerebellum. It is associated with the T cell receptor (TCR) and is responsible for its signal transduction. The CD3 antigen is a complex of five invariable chains: gamma, delta, epsilon, zeta, and eta. The epitope recognized by the antibody is located on the epsilon-chain of the CD3 complex. Additional information: Clone REA613 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD3-PE (Clone REA613)
Version/Model Number
170-081-055
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
9977170d-e450-4afc-a48a-aec8749e1eb7
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 |