An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Vaccines, Blood & Biologics

Blood Group Regent, Anti-B (Murine Monoclonal)

STN#: 125435
Proper Name: Blood Grouping Reagent, Anti-B (Murine Monoclonal) (For Further Manufacturing Use)(FFMU)
Tradename: (NONE)
Manufacturer: DIAGAST, License #1887
Indication:

This and other Blood Grouping Reagents (For Further Manufacturing Use) listed in the approval letter are indicated for use in the manufacture of Blood Grouping Reagents, Anti-B, Anti-D and Anti-E by Diagnostic Grifols S.A. (Spain) U.S. License No. 1887, to produce in vitro product Blood Grouping Reagents (BGR) under a shared manufacturing arrangement.

Supporting Documents

Supporting Documents older than three years - Blood Grouping Reagent, Anti-B (Murine Monoclonal)

Top