Duns Number:381527001
Device Description: Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal Blend) (P3X61+P3X21223B10+P3X290+P Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal Blend) (P3X61+P3X21223B10+P3X290+P3X35) - This reagents are designed to determine the presence of the blood Rhesus antigen D (RH1) on the surface of human red blood cells by manual tube and gel agglutination methods.
Catalog Number
210526
Brand Name
Anti-D (RH1) IgM+IgG
Version/Model Number
210526
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
0b767f81-281a-4d9b-9e8f-5513dac787c2
Public Version Date
June 26, 2020
Public Version Number
3
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 |