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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Blood Grouping Reagent Anti-A (DAM1, LA2) Murine Monoclonal IgM

STN#: 125438
Proper Name: Blood Grouping Reagent, Anti-A (Murine Monoclonal) For Further Manufacturing Use (FFMU)
Tradename: (None)
Manufacturer: Alba Bioscience Limited, License #1807
Indication:

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