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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Captia Mycoplasma IgG
Classification Name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Product Code: LON
Device Class: 2
Regulation Number: 866.1645
Medical Specialty: Microbiology
Registered Establishment Name: TRINITY BIOTECH USA
Registered Establishment Number: 1318354
Owner/Operator: TRINITY BIOTECH, PLC
Owner/Operator Number: 9025161
Establishment Operations: Manufacturer
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