MAGIC DIGOXIN IMMUNOASSAY MANUFACTURED BY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Address	333 CONEY ST.
City, State, Zip	WALPOLE, MA 02032
Country	US
FDA Owner/Operator Phone	914-524-2955
FDA Medical Specialty Code	TX - Clinical Toxicology
FDA Product Code	LCS
FDA Classification Name	RADIOIMMUNOASSAY, DIGOXIN (125-I)
FDA Device Classification Code	Standards
FDA Regulation Number	862.3320
FDA Common Generic Name	MAGIC DIGOXIN 100 TEST KIT ANTIBODY/TRACER
FDA Proprietary Device Name	MAGIC DIGOXIN IMMUNOASSAY
FDA Owner / Operator Number	9096044
FDA Owner / Operator Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Establishment Registration Number	1219913
FDA Registered Establishment Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	07-25-98
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	MULTIPLE	DIGOXIN ASSAY
2	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	MULTIPLE	DIGOXIN ASSAY
3	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	AUTOPAK DIGOXIN ANTIBODY COATED TUBE, IMMUCHEM DIGOXIN ANTIBODY COATED TUBE	PROCEDURE FOR THE RIA OF DIGOXIN