GAP-IGG 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	DFZ
FDA Classification Name	IGG (GAMMA CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5510
FDA Common Generic Name	ELIZA TEST FOR DETECTION OF HELICOBACTER PYLORI SPECIFIC IGG ANTIBODIES
FDA Proprietary Device Name	GAP-IGG
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 MS - Specification Developer
FDA Listing Date
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	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	GOAT OR RABBIT ANTISERA TO HUMAN IGG (GAMMA CHAIN SPECIFIC)	GOAT OR RABBIT ANTISERA TO HUMAN IGG (GAMMA CHAIN SPECIFIC)
2	KENT LABORATORIES, INC. 777 JORGENSEN PLACE BELLINGHAM, WA 98226 US 360-398-8641 / 360-398-8641	ANTI RABBIT IGG, (H&L CHAIN) ANTISERUM	ANTI RABBIT IGG, (H&L CHAIN) ANTISERUM
3	THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000	IGG SUBCLASS SINGLE DILUTION NEPH KIT	IGG SUBCLASS SINGLE DILUTION NEPH KIT