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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: MONOLISA anti-HAV IgM EIA on EVOLIS
Classification Name: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
Product Code: LOL
Device Class: 2
Regulation Number: 866.3310
Medical Specialty: Microbiology
Registered Establishment Name: BIO-RAD
Registered Establishment Number: 8023060
Owner/Operator: BIO-RAD
Owner/Operator Number: 8023061
Establishment Operations: Manufacturer
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