DIGOXIN,SOLID PHASE RADIOIMMUNOASSAY 125 I SINGLE LOT COMPONENT SYSTEM 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	DON
FDA Classification Name	RADIOIMMUNOASSAY, DIGOXIN (125-I), RABBIT ANTIBODY, SOLID PHASE SEP.
FDA Device Classification Code	Standards
FDA Regulation Number	862.3320
FDA Common Generic Name	DIGOXIN RADIOIMMUNOASSAY SYSTEM 125 I
FDA Proprietary Device Name	DIGOXIN,SOLID PHASE RADIOIMMUNOASSAY 125 I SINGLE LOT COMPONENT SYSTEM
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	06-20-95
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	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	DIGOXIN MULTIPLE DIAGNOSIS PRODUCTS	DIGOXIN MULTIPLE DIAGNOSIS PRODUCTS
2	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS DIGOXIN ASSAY	DIGOXIN