IMMULITE / IMMULITE 1000 ALLERGY FOOD PANEL FP5E MANUFACTURED BY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Address	5210 PACIFIC CONCOURSE DR.
City, State, Zip	LOS ANGELES, CA 90045
Country	US
FDA Owner/Operator Phone	914-524-2955
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	DGO
FDA Classification Name	IGE, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5510
FDA Common Generic Name	IMMUNOASSAY FOR THE DETECTION OF IGE ANTIBODY-SPECIFIC TO A PANEL OF FOOD ALLERG
FDA Proprietary Device Name	IMMULITE / IMMULITE 1000 ALLERGY FOOD PANEL FP5E
FDA Owner / Operator Number	9096044
FDA Owner / Operator Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Establishment Registration Number	3005250747
FDA Registered Establishment Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	04-07-05
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	BIOMERICA, INC. 1533 MONROVIA AVE. NEWPORT BEACH, CA 92663 US 949-645-2111 / 949-645-2111 330	SOLID PHASE HIGE (ELISA) NMS #1070 FOR THE QUANTATIVE DETERM	ENZYME IMMUNO ASSAY KIT (COLORMETRIC)
2	DEXALL BIOMEDICAL LABS, INC. 18904 BONANZA WAY GAITHERSBURG, MD 20879 US / 301-840-1884	ALLERG.E/ACTI.TIP	ENZYME IMMUNOASSAY FOR TOTAL IGE IN SERUM
3	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	IGE MULTIPLE DIAGNOSIS PRODUCTS	IGE MULTIPLE DIAGNOSIS PRODUCTS
4	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	IGE, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL	IGE, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL
5	SENITH BIOMED TEORANTA TULLY INDUSTRIAL PARK, BALLYNAHOWN CO. GALWAY, EI 353-91-593900 / 353-91-593900	IGE, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL (MULTIPLE BRANDS)	TOTAL IGE TEST (VARIOUS TYPES OF)
6	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE(R)(FP5E) ALLERGY FOOD PANEL	IMMUNOASSAY FOR THE DETECTION OF IGE SPECIAL SERUM TO A PANEL OF FOOD ALLERGIES