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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: (HBcAb); Hepatitis B Core Total Antibody
Classification Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
Product Code: LOM
Device Class: 3
Registered Establishment Name: Diagnostic Automation/ Cortez Diagnostics Inc,.
Registered Establishment Number: 2029372
Owner/Operator: Diagnostic Automation /Cortez Diagnostics Inc.
Owner/Operator Number: 9011974
Establishment Operations: Manufacturer
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