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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: MicroScan Dried Gram-Positive MIC/Combo Panels with Ceftaroline
Classification Name: SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL
Product Code: LTW
Device Class: 2
Regulation Number: 866.1640
Medical Specialty: Microbiology
Registered Establishment Name: Siemens Healthcare Diagnostics Inc.
Registered Establishment Number: 2919016
Owner/Operator: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Owner/Operator Number: 9096044
Establishment Operations: Manufacturer; Repackager/Relabeler; U.S. Manufacturer of Export Only Devices
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