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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Blood Group Reagent Anti-c (H48) Human/Murine Monoclonal (IgM)

STN#: 125440
Proper Name:
Blood Grouping Reagent (For Further Manufacturing Use) Anti-c (H48) Human/Murine Monoclonal IgM
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.