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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Blood Grouping Reagent, Anti-D (Human Monoclonal)

STN#: 125442
Proper Name: Blood Grouping Reagent, Anti-D (Human Monoclonal) (For Further Manufacturing) (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.