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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: PathVysion HER-2 100 Assay 02J01-036; PATHVYSION HER-2 100 TEST; PATHVYSION HER-2 20 ASSAY; PathVysion HER-2 20 Assay 02J01-030; PATHVYSION HER-2 50 ASSAY; PathVysion HER-2 50 Assay 02J01-035; ProbeCheck Slides 02J04-030, 02J05-030
Classification Name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Product Code: MVD
Device Class: 3
Registered Establishment Name: ABBOTT MOLECULAR, INC.
Registered Establishment Number: 3005248192
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer
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