MULTIPLE MANUFACTURED BY ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.

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MULTIPLE

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	TX - Clinical Toxicology
FDA Product Code	KLT
FDA Classification Name	ENZYME IMMUNOASSAY, CARBAMAZEPINE
FDA Device Classification Code	Standards
FDA Regulation Number	862.3645
FDA Common Generic Name	VARIOUS ASSAYS FOR DETECTION OF CARBAMAZEPINE
FDA Proprietary Device Name	MULTIPLE
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	09-05-00
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.

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	MULTIPLE	VARIOUS ASSAYS FOR DETECTION OF CARBAMAZEPINE
2	ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS ASSAYS FOR DETECTION OF CARBAMAZEPINE
3	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	CARBAMEZAPINE
4	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	CARBAMEZAPINE
5	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	EMIT CONVENIENCE PACK	CARBAMAZEPINE EIA
6	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	ACA CARBAMAZEPINE (CRBAM) ANALYTICAL TEST PACK	VARIOUS CRBAM METHODS
7	JANT PHARMACAL CORP. 16255 VENTURA BLVD., SUITE 505 ENCINO, CA 91436 US 818-986-8530 / 818-986-8530	ACCUTEST TCA DRUG SCREEN	LATERAL FLOW, ONE-STEP IMMUNOASSAY FOR QUALITATIVE DETECTION OF TCA IN HUMAN URI
8	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	CEDIA CARBAMAZEPINE II ASSAY	HOMOGENEOUS ENZYME IMMUNOASSAY FOR THE DETERMINATION OF CARBAMAZEPINE IN SERUM A
9	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	CEDIA CARBAMAZEPINE II ASSAY	HOMOGENEOUS ENZYME IMMUNOASSAY FOR THE DETERMINATION OF CARBAMAZEPINE IN SERUM A
10	ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	VITORS CHEMISTRY PRODUCTS CRBM	CARBAMAZEPINE ASSAY
11	POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363	POLYMEDCO POLY-CHEM SYSTEM, CARBAMAZEPINE	CARBAMAZEPINE, TEGRETOL
12	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX CARBAMAZEPINE	CARBAMAZEPINE
13	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX CARBAMAZEPINE	CARBAMAZEPINE
14	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX CARBAMAZEPINE	CARBAMAZEPINE
15	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX CARBAMAZEPINE	CARBAMAZEPINE
16	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	MULTIPLE	CARBAMAZEPINE EIA ASSAY
17	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 CARBAMAZEPINE	IMMUNOASSAY FOR THE MEASUREMENT OF CARBAMAZEPINE
18	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	CARBAMAZEPINE TEST SYSTEM
19	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 CARBAMAZEPINE	IMMUNOASSAY FOR THE MEASUREMENT OF CARBAMAZEPINE
20	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 CARBAMAZEPINE	IMMUNOASSAY FOR THE MEASUREMENT OF CARBAMAZEPINE

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