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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Classification Name: SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY
Product Code: KSZ
Device Class: 2
Regulation Number: 864.9175
Medical Specialty: Hematology
Registered Establishment Name: DIAGNOSTIC GRIFOLS, S.A.
Registered Establishment Number: 3002772505
Premarket Submission Number: BK190321
Owner/Operator: DIAGNOSTIC GRIFOLS, S.A.
Owner/Operator Number: 9050426
Establishment Operations: Manufacturer
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