Duns Number:381527001
Device Description: Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal) (P3GD512+MS63) - This reagent is Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal) (P3GD512+MS63) - This reagent is designed to determine the presence of the blood group antigen e (Rh5) on the surface of human red blood cells by manual tube method.
Catalog Number
210230
Brand Name
Anti-e (RH5)
Version/Model Number
210530
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)
Yes
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
-
Product Code Name
-
Public Device Record Key
7323814f-2430-40b5-bbb5-bf6b4b63ca52
Public Version Date
October 21, 2020
Public Version Number
2
DI Record Publish Date
May 01, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |