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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: PTDCheck; QuikCheck fFN; Rapid fFN 10Q System
Classification Name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Product Code: LKV
Device Class: 3
Registered Establishment Name: Hologic, Inc.
Registered Establishment Number: 2939852
Owner/Operator: HOLOGIC, INC.
Owner/Operator Number: 9007676
Establishment Operations: U.S. Manufacturer of Export Only Devices
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