AUTOPAK DIGOXIN ANTIBODY COATED TUBE, IMMUCHEM DIGOXIN ANTIBODY COATED TUBE MANUFACTURED BY MP BIOMEDICALS DIAGNOSTICS DIVISION

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Request for Information Form	Contact Information
Company Name	MP BIOMEDICALS DIAGNOSTICS DIVISION
Address	29525 FOUNTAIN PARKWAY
City, State, Zip	SOLON, OH 44139
Country	US
FDA Owner/Operator Phone	949-833-2500
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	PROCEDURE FOR THE RIA OF DIGOXIN
FDA Proprietary Device Name	AUTOPAK DIGOXIN ANTIBODY COATED TUBE, IMMUCHEM DIGOXIN ANTIBODY COATED TUBE
FDA Owner / Operator Number	9057708
FDA Owner / Operator Name	MP BIOMEDICALS, LLC
FDA Establishment Registration Number	2419955
FDA Registered Establishment Name	MP BIOMEDICALS DIAGNOSTICS DIVISION
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	07-11-96
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	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	MAGIC DIGOXIN IMMUNOASSAY	MAGIC DIGOXIN 100 TEST KIT ANTIBODY/TRACER