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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.