IMMULITE, IML 2000, IML 2500 UNCONJUGATED ESTRIOL MANUFACTURED BY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

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IMMULITE, IML 2000, IML 2500 UNCONJUGATED ESTRIOL

Request for Information Form	Contact Information
Company Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Address	5210 PACIFIC CONCOURSE DR.
City, State, Zip	LOS ANGELES, CA 90045
Country	US
FDA Owner/Operator Phone	914-524-2955
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CGI
FDA Classification Name	RADIOIMMUNOASSAY, ESTRIOL
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1265
FDA Common Generic Name	IMMUNOASSAY FOR MEASUREMENT OF UNCONJUGATED (FREE) ESTRIOL
FDA Proprietary Device Name	IMMULITE, IML 2000, IML 2500 UNCONJUGATED ESTRIOL
FDA Owner / Operator Number	9096044
FDA Owner / Operator Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Establishment Registration Number	3005250747
FDA Registered Establishment Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	10-04-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

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 DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471	MULTIPLE: TDX/TDX FLX FREE AND TOTAL ESTRIOL ASSAYS	VARIOUS ESTRIOL ASSAYS
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE: TDX/TDX FLX FREE AND TOTAL ESTRIOL ASSAYS	VARIOUS ESTRIOL ASSAYS
3	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS UNCONJUGATED ESTRIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	UNCONJUGATED ESTRIOL EIA
4	BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	VARIOUS
5	BIOMERICA, INC. 1533 MONROVIA AVE. NEWPORT BEACH, CA 92663 US 949-645-2111 / 949-645-2111 330	NMS #1009 ESTRIOL KIT	INVITRO DIAGNOSTIC DETERMINATION OF ESTRIOL IN SERUM OR PLASMA
6	CALBIOTECH, INC. 10461 AUSTIN DR., #G SPRING VALLEY, CA 91978 US 619-660-6162 / 619-660-6162	ELISA ESTRIOL TEST SYSTEM, ESTRIOL EASY ELISA	ESTRIOL ELISA
7	DEMEDITEC DIAGNOSTICS LISE-MEITNER-STRASSE 2 KIEL-WELLSEE, D-24145 GM 49-431-7192251 / 763-780-2955	DEMEDITEC ESTRIOL TEST SYSTEM	ESTRIOL TEST SYSTEM
8	DRG INSTRUMENTS GMBH FRAUENBERGSTRASSE 18 MARBURG, D-35039 GM 908-233-2079 / 908-233-2079	ESTRIOL TEST SYSTEM	ESTRIOL
9	IBL GMBH FLUGHAFENSTRASSE, 52A HAMBURG, D-22335 GM 49-40-53289122 / 715-294-1752	IBL ESTRIOL TEST SYSTEM	IBL ESTRIOL TEST SYSTEM
10	IMMUNALYSIS CORPORATION 829 TOWNE CENTER DR. POMONA, CA 91767 US 909-482-0840 / 909-482-0840	FREE ESTRIOL DIRECT RIA KIT	RIA METHOD TO DETERMINE FREE ESTRIOL
11	LABOR DIAGNOSTIKA NORD GMBH & CO. KG AM EICHENHAIN 1 NORDHORN, 48531 GM 49-592-1855105 / 49-592-172728105	MULTIPLE	ESTRIOL RIA, ESTRIOL ELISA, ESTRIOL(FREE) ELISA
12	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	ESTRIOL ELISA	ESTRIOL ELISA
13	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 2000, IML 2500 UNCONJUGATED ESTRIOL	IMMUNOASSAY FOR MEASUREMENT OF UNCONJUGATED (FREE) ESTRIOL
14	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851	MULTIPLE	VARIOUS TYPES OF UNCONJUGATED ESTRIOL TEST KITS
15	WALLAC OY MUSTIONKATU 6 TURKU, 20750 FI 781-663-6900 / 358-226-78111	AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT	FLUROIMMUNOASSAY FOR THE DETERMINATION OF ESTRIOL