125I DIGOXIN COAT-A-COUNT MANUFACTURED BY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Address	5700 WEST 96TH ST.
City, State, Zip	LOS ANGELES, CA 90045
Country	US
FDA Owner/Operator Phone	914-524-2955
FDA Medical Specialty Code	TX - Clinical Toxicology
FDA Product Code	DNL
FDA Classification Name	RADIOIMMUNOASSAY, DIGOXIN (125-I), RABBIT ANTIBODY, SECOND ANTIBODY SEP.
FDA Device Classification Code	Standards
FDA Regulation Number	862.3320
FDA Common Generic Name	DIGOXIN RIA TEST
FDA Proprietary Device Name	125I DIGOXIN COAT-A-COUNT
FDA Owner / Operator Number	9096044
FDA Owner / Operator Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Establishment Registration Number	2017183
FDA Registered Establishment Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-28-92
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	ANTIBODIES INC. 25242 CR 95 DAVIS, CA 95616 US 530-758-4400 / 530-758-4400	125-I DIGOXIN SECOND ANTIBODY SYSTEM	DIGOXIN RIA KIT
2	MONOBIND, INC. 100 N. POINTE DR. LAKE FOREST, CA 92630 US 949-951-2665 / 949-951-2665		DIGOXIN RADIOIMMUNOASSAY TEST SYSTEM