SOLID PHASE HIGE (ELISA) NMS #1070 FOR THE QUANTATIVE DETERM MANUFACTURED BY BIOMERICA, INC.

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Request for Information Form	Contact Information
Company Name	BIOMERICA, INC.
Address	1533 MONROVIA AVE.
City, State, Zip	NEWPORT BEACH, CA 92663
Country	US
FDA Owner/Operator Phone	949-645-2111
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	ENZYME IMMUNO ASSAY KIT (COLORMETRIC)
FDA Proprietary Device Name	SOLID PHASE HIGE (ELISA) NMS #1070 FOR THE QUANTATIVE DETERM
FDA Owner / Operator Number	2016793
FDA Owner / Operator Name	BIOMERICA, INC.
FDA Establishment Registration Number	2016793
FDA Registered Establishment Name	BIOMERICA, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	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
2	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
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4	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)
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6	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE / IMMULITE 1000 ALLERGY FOOD PANEL FP5E	IMMUNOASSAY FOR THE DETECTION OF IGE ANTIBODY-SPECIFIC TO A PANEL OF FOOD ALLERG