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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: (HAV Ab IgM); Hepatitis A Virus IgM Antibody
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: 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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