RIA, IMMULITE, IML 1000, IML 2000, IML 2500 DHEA-SO4 MANUFACTURED BY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

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RIA, IMMULITE, IML 1000, IML 2000, IML 2500 DHEA-SO4

Request for Information Form	Contact Information
Company Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Address	5700 WEST 96TH ST.
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	JKC
FDA Classification Name	RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1245
FDA Common Generic Name	IMMUNOASSAY FOR MEASUREMENT OF DEHYDROEPIANDROSTERON
FDA Proprietary Device Name	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 DHEA-SO4
FDA Owner / Operator Number	9096044
FDA Owner / Operator Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Establishment Registration Number	2017183
FDA Registered Establishment Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	10-02-06
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	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS DHEA-S REAGENT ACCESS DHEA-S CALIBRATORS	DEHYDROEPIANDROSTERONE (FREE AND SULFATE) TEST SYSTEM
2	BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	VARIOUS
3	BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000	ARCHITECT DHEA-S	CHEMILUMINISCENT DHEA-S TEST
4	BIOMERICA, INC. 1533 MONROVIA AVE. NEWPORT BEACH, CA 92663 US 949-645-2111 / 949-645-2111 330	DEHA RIA NMS #1017	RADIOIMMUNOASSAY FOR DEHYODROEPIANDROSTERONE SULFATE IN SERUM OR PLASMA
5	CALBIOTECH, INC. 10461 AUSTIN DR., #G SPRING VALLEY, CA 91978 US 619-660-6162 / 619-660-6162	DHEA-S ENZYME LINKED IMMUNOSORBENT ASSAY	DHEA-S ELISA
6	DEMEDITEC DIAGNOSTICS LISE-MEITNER-STRASSE 2 KIEL-WELLSEE, D-24145 GM 49-431-7192251 / 763-780-2955	DEMEDITEC DHEA-S ELISA KIT	DHEA-S ELISA KIT
7	DIAGNOSTICS BIOCHEM CANADA, INC. 1020 HARGRIEVE RD. LONDON, ONTARIO, N6E 1P5 CA 519-681-8731 / 519-681-8731	DEHYDROEPIANDROSTERONE (FREE AND SULFATE) BY ENZYMEIMMUNOASSAY (EIA)	DEHYDROEPIANDROSTERONE (FREE AND SULFATE) ENZYMEIMMUNOASSAY TEST SYSTEM
8	DRG INSTRUMENTS GMBH FRAUENBERGSTRASSE 18 MARBURG, D-35039 GM 908-233-2079 / 908-233-2079	DEHYDROEPIANDROSTERONE (FREE AND SULFATE) TEST SYSTEM	DHEA
9	DRG INTL., INC. 1167 US HIGHWAY 22 MOUNTAINSIDE, NJ 07092 US 908-233-2079 / 908-233-2075	DRG AURICA DHEAS ELISA TEST	DHEAS ELISA KIT, EIA1562
10	IBL GMBH FLUGHAFENSTRASSE, 52A HAMBURG, D-22335 GM 49-40-53289122 / 715-294-1752	IBL DHEA-S ELISA TEST KIT	IBL DHEA-S ELISA TEST KIT
11	IMMUNALYSIS CORPORATION 829 TOWNE CENTER DR. POMONA, CA 91767 US 909-482-0840 / 909-482-0840	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
12	LABOR DIAGNOSTIKA NORD GMBH & CO. KG AM EICHENHAIN 1 NORDHORN, 48531 GM 49-592-1855105 / 49-592-172728105	MULTIPLE	DHEA ELISA
13	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	IMMUCHEM DHEA-SULFATE DOUBLE ANTIBODY, IMMUCHEM DHEA-SULFATE ANTIBODY COATED TUB	IMMUCHEM DHEA-SULFATE DOUBLE ANTIBODY, IMMUCHEM DHEA-SULFATE ANTIBODY COATED TUB
14	NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO SAN CLEMENTE, CA 92673 US 949-940-7200 / 949-940-7465	CHEMILUMINESCENCE DHEA SULFATE ONLY TEST SYSTEM	DHEA SULFATE ONLY TEST SYSTEM
15	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	ELECSYS DHEA S ASSAY	RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)
16	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS DHEA-S ASSAY	DHEA-S ASSAY
17	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 DHEA-SO4	IMMUNOASSAY FOR MEASUREMENT OF DEHYDROEPIANDROSTERON
18	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 DHEA-SO4	IMMUNOASSAY FOR MEASUREMENT OF DEHYDROEPIANDROSTERON
19	TOSOH BIOSCIENCE, INC. 3600 GANTZ ROAD GROVE CITY, OH 43123 US 813-542-75118 / 614-317-1909	AIA-PACK C-PEPTIDE, ST AIA-PACK C-PEPTIDE	DEHYDROEPIANDROSTERONE (FREE AND SULFATE) TEST SYSTEM