Duns Number:119240658
Device Description: URL: https://www.biolegend.com/en-us/products/percpcyanine55-anti-human-cd38-21401?Clone=H URL: https://www.biolegend.com/en-us/products/percpcyanine55-anti-human-cd38-21401?Clone=HIT2
Catalog Number
980314
Brand Name
PerCP/Cyanine5.5 anti-human CD38
Version/Model Number
980314
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
aeecc7c7-d08d-42a3-91b4-3439120e407e
Public Version Date
April 20, 2022
Public Version Number
1
DI Record Publish Date
April 12, 2022
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 | 209 |