AVL OMNI ANALYZER MANUFACTURED BY ROCHE DIAGNOSTICS CORP.

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Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS CORP.
Address	KRATKYSTRASSE 2
City, State, Zip	GRAZ,
Country	AU
FDA Owner/Operator Phone	433-162-7787
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GLY
FDA Classification Name	OXIMETER TO MEASURE HEMOGLOBIN
FDA Device Classification Code	Standards
FDA Regulation Number	864.7500
FDA Common Generic Name	AUTOMATED PH/BLOOD GAS/ELECTROLYTE/CO-OXIMETRY ANALYZER
FDA Proprietary Device Name	AVL OMNI ANALYZER
FDA Owner / Operator Number	8020003
FDA Owner / Operator Name	ROCHE DIAGNOSTICS CORP.
FDA Establishment Registration Number	8020003
FDA Registered Establishment Name	ROCHE DIAGNOSTICS CORP.
FDA Operation Code(s)
FDA Listing Date	12-28-95
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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8	WATERS MEDICAL SYSTEMS, LLC 2112 15TH ST. N.W., SUITE A ROCHESTER, MN 55901 US 212-583-4920 / 507-252-3748	OXICOM-3000 WHOLE BLOOD OXIMETER	BLOOD OXIMETER