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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: MONOLISA Anti-HBs EIA; MONOLISA Anti-HBc EIA; MONOLISA Anti-HBc IgM EIA; MONOLISA Anti-HBs Calibrator Kit; MONOLISA Anti-HBs EIA
Classification Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
Product Code: LOM
Device Class: 3
Registered Establishment Name: BIO-RAD LABORATORIES, INC.
Registered Establishment Number: 3022521
Owner/Operator: BIO-RAD LABORATORIES, INC.
Owner/Operator Number: 3022521
Establishment Operations: Manufacturer
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