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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: DML 3000; hc2 High-Risk HPV DNA Test; hc2 High-Risk HPV DNA Test (4 Plate Kit); hc2 HPV DNA Test (High Risk and Low Risk); Hybrid Capture 2 (hc2) System Core, 120V
Classification Name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Product Code: MAQ
Device Class: 3
Registered Establishment Name: QIAGEN Gaithersburg, Inc.
Registered Establishment Number: 1122376
Owner/Operator: QIAGEN Gaithersburg Inc.
Owner/Operator Number: 9002668
Establishment Operations: Manufacturer; Specification Developer
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