DHEA-S ENZYME LINKED IMMUNOSORBENT ASSAY MANUFACTURED BY CALBIOTECH, INC.

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DHEA-S ENZYME LINKED IMMUNOSORBENT ASSAY

Request for Information Form	Contact Information
Company Name	CALBIOTECH, INC.
Address	10461 AUSTIN DR., #G
City, State, Zip	SPRING VALLEY, CA 91978
Country	US
FDA Owner/Operator Phone	619-660-6162
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	DHEA-S ELISA
FDA Proprietary Device Name	DHEA-S ENZYME LINKED IMMUNOSORBENT ASSAY
FDA Owner / Operator Number	9046880
FDA Owner / Operator Name	CALBIOTECH, INC.
FDA Establishment Registration Number	2090110
FDA Registered Establishment Name	CALBIOTECH, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	06-15-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of CALBIOTECH, INC.

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	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
6	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
7	DRG INSTRUMENTS GMBH FRAUENBERGSTRASSE 18 MARBURG, D-35039 GM 908-233-2079 / 908-233-2079	DEHYDROEPIANDROSTERONE (FREE AND SULFATE) TEST SYSTEM	DHEA
8	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
9	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
10	IMMUNALYSIS CORPORATION 829 TOWNE CENTER DR. POMONA, CA 91767 US 909-482-0840 / 909-482-0840	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
11	LABOR DIAGNOSTIKA NORD GMBH & CO. KG AM EICHENHAIN 1 NORDHORN, 48531 GM 49-592-1855105 / 49-592-172728105	MULTIPLE	DHEA ELISA
12	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
13	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
14	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS DHEA-S ASSAY	DHEA-S ASSAY
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	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. 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
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