MULTIPLE: ARCHITECT/AXSYM/IMX FREE PSA MANUFACTURED BY ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.

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MULTIPLE: ARCHITECT/AXSYM/IMX FREE PSA

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	IM - Immunology
FDA Product Code	MTG
FDA Classification Name	TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	FREE PSA
FDA Proprietary Device Name	MULTIPLE: ARCHITECT/AXSYM/IMX FREE PSA
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	06-01-01
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: ARCHITECT/AXSYM/IMX FREE PSA	FREE PSA
2	AMERITEK USA, INC. 125 130 ST. SE, #200 EVERETT, WA 98208 US 425-379-2580 / 425-379-2580	DBEST ONE STEP PSA TEST KIT	PSA TEST KIT
3	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	FREE PROSTATE SPECIFIC ANTIGEN (FREE PSA) REAGENTS	VARIOUS
4	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	FREE PSA	FREE PSA
5	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	PSA MULTIPLE DIAGNOSIS PRODUCTS	PSA MULTIPLE DIAGNOSIS PRODUCTS
6	QUALIGEN, INC. 2042 CORTE DEL NOGAL CARLSBAD, CA 92011 US 760-918-9165 / 760-918-9165 226	FAST PACK TM FREE PSA IMMUNOASSAY	CHEMI IMINESCENCE ASSAY FOR THE DETERMINATION OF FREE PROSTATE SPECIFIC ANTIGEN
7	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE FREE PSA	IMMUNO METRIC ASSAY FOR MEASUREMENT OF FREE PSA
8	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE / IMMULITE 1000 FREE PSA	IMMUNOASSAY FOR THE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA)
9	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	COAT-A-COUNT FREE PSA IRMA	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF FREE PSA TEST, PROSTATE SPECIFIC