IMX B12 MANUFACTURED BY ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.

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Request for Information Form	Contact Information
Company Name	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
Address	KM 58.0, CARRETERA 2 CRUCE DAVILA
City, State, Zip	BARCELONETA, PR 00617
Country	US
FDA Owner/Operator Phone	847-937-6100
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	LIG
FDA Classification Name	RADIOASSAY, INTRINSIC FACTOR BLOCKING ANTIBODY
FDA Device Classification Code	Standards
FDA Regulation Number	862.1810
FDA Common Generic Name	ENZYME ASSAY TO DETECT VITAMIN B12 IN HUMAN SERUM OR PLASMA
FDA Proprietary Device Name	IMX B12
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	2623532
FDA Registered Establishment Name	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-01-97
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	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	IMX B12	ENZYME ASSAY TO DETECT VITAMIN B12 IN HUMAN SERUM OR PLASMA
2	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	INTRINSIC FACTOR AB, INTRINSIC FACTOR AB CALIBRATORS AND INTRINSIC FACTOR AB QC	INTRINSIC FACTOR AB CHEMILUMINESCENCE IMMUNOASSAY
3	INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131 US 858-586-9900 / 858-586-9900 351	QUANTA PLEX	INSTRINSIC FACTOR
4	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE 2000 VITAMIN B12	IMMUNOASSAY FOR THE MEASUREMENT OF VITAMIN B12
5	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE 2000 VITAMIN B12	IMMUNOASSAY FOR THE MEASUREMENT OF VITAMIN B12