Duns Number:342920388
Device Description: LT2 recognizes the human CD2 antigen, a 50 kDa single-chain transmembrane glycoprotein als LT2 recognizes the human CD2 antigen, a 50 kDa single-chain transmembrane glycoprotein also known as LFA-2 or receptor for sheep erythrocytes. CD2 belongs to the Ig superfamily and is involved in cell signaling and lymphocyte adhesion. The CD2 antibody reacts with 80–90 % of peripheral blood lymphocytes and more than 95 % of thymocytes. The antibody recognizes all T cells and a subset of NK cells.
Catalog Number
-
Brand Name
CD2-FITC
Version/Model Number
170-081-028
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"
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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)
-
FDA Premarket Submission
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
bdf56a61-cdeb-470f-b893-05341e9829a2
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 |