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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 (EVOLIS)
Classification Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Product Code: JJE
Device Class: 1
Regulation Number: 862.2160
Medical Specialty: Clinical Chemistry
Registered Establishment Name: Bio-Rad Service France SAS
Registered Establishment Number: 3035708936
Premarket Submission Number: K092353
Owner/Operator: Bio-Rad Laboratories (Bio-Rad Services France)
Owner/Operator Number: 10078397
Establishment Operations: Foreign Exporter
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