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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: IMMULITE 2000 AFP; IMMULITE AFP; IMMULITE AFP Control
Classification Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Product Code: LOK
Device Class: 3
Registered Establishment Name: Siemens Healthcare Diagnostics Inc.
Registered Establishment Number: 2017183
Owner/Operator: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner/Operator Number: 9096044
Establishment Operations: Contract Manufacturer; Manufacturer; Specification Developer; U.S. Manufacturer of Export Only Devices
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