DEMEDITEC PROGESTERONE ELISA KIT MANUFACTURED BY DEMEDITEC DIAGNOSTICS

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DEMEDITEC PROGESTERONE ELISA KIT

Request for Information Form	Contact Information
Company Name	DEMEDITEC DIAGNOSTICS
Address	LISE-MEITNER-STRASSE 2
City, State, Zip	KIEL-WELLSEE,
Country	GM
FDA Owner/Operator Phone	49-431-7192251
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JLS
FDA Classification Name	RADIOIMMUNOASSAY, PROGESTERONE
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1620
FDA Common Generic Name	PROGESTERONE ELISA
FDA Proprietary Device Name	DEMEDITEC PROGESTERONE ELISA KIT
FDA Owner / Operator Number	9083404
FDA Owner / Operator Name	DEMEDITEC DIAGNOSTICS
FDA Establishment Registration Number	3005542422
FDA Registered Establishment Name	DEMEDITEC DIAGNOSTICS
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	02-07-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of DEMEDITEC 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 LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	PROGESTERONE
2	ADALTIS S.P.A. DIAGNOSTICS PLANT VIA LUIGI EINAUDI, 7 GUIDONIA MONTECELIO, ROMA, 00012 IT 514-335-9922 / 514-335-9922	RADIOIMMUNOASSAY, PROGESTERONE (MULTIPLE BRANDS)	PROGESTERONE RADIOIMMUNOASSAY KIT
3	BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	VARIOUS
4	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS PROGESTERONE REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	PROGESTERONE EIA (ENZYME IMMUNOASSAY)
5	BIOCHECK, INC. 323 VINTAGE PARK DR. FOSTER CITY, CA 94404 US / 650-573-1968	BIOCHECK PROGESTERONE EIA TEST KIT	PROGESTERONE EIA TEST KIT
6	BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594	VIDAS PROGESTERONE (PRG) ASSAY	ENZYME-LINKED FLUORESCENT IMMUNOASSAY (ELFA)
7	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594	VIDAS PROGESTERONE (PRG) ASSAY	ENZYME-LINKED FLUORESCENT IMMUNOASSAY (ELFA)
8	CALBIOTECH, INC. 10461 AUSTIN DR., #G SPRING VALLEY, CA 91978 US 619-660-6162 / 619-660-6162	ELISA PROGESTERONE ELISA, PRGESTERON EASY ELISA	PROGESTERONE ELISA
9	CTK BIOTECH, INC. 6748 NANCY RIDGE DR. SAN DIEGO, CA 92121 US 858-457-8698 / 858-457-8698	PROGESTERONE DETECT ELISA KIT	PROGESTERONE ELISA KIT
10	DIAGNOSTICS BIOCHEM CANADA, INC. 1020 HARGRIEVE RD. LONDON, ONTARIO, N6E 1P5 CA 519-681-8731 / 519-681-8731	PROGESTERONE BY ENZYME IMMUNOASSAY (EIA)	PROGESTERONE ENZYME IMMUNOASSAY TEST SYSTEM
11	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	GAMMA COAT PROGESTERONE RADIOIMMUNOASSAY	PROGESTERONE RADIOIMMUNOASSAY
12	DRG INSTRUMENTS GMBH FRAUENBERGSTRASSE 18 MARBURG, D-35039 GM 908-233-2079 / 908-233-2079	PROGESTERONE TEST SYSTEM	PROGESTERONE
13	DRG INTL., INC. 1167 US HIGHWAY 22 MOUNTAINSIDE, NJ 07092 US 908-233-2079 / 908-233-2075	DRG AURICA ELISA PROGESTERONE KIT	PROGESTERONE ELISA KIT EIA1561
14	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	GLOBALEMED PROGESTERONE EIA	PROGESTERONE EIA TEST
15	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	RADIOIMMUNOASSAY, PROGESTERONE	RADIOIMMUNOASSAY, PROGESTERONE
16	IBL GMBH FLUGHAFENSTRASSE, 52A HAMBURG, D-22335 GM 49-40-53289122 / 715-294-1752	IBL PROGESTERONE LIA TEST KIT	PROGESTERONE LIA TEST KIT
17	IFCI/CLONESYSTEMS SPA VIA MAGNANELLI 2 CASALECCHIO DI RENO, 40033 IT	EIAGEN PROGESTERONE	PROGESTERONE
18	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	MULTIPLE	PROGESTERONE
19	ORTHO-CLINICAL DIAGNOSTICS FOREST FARM ESTATE WHITCHURCH CARDIFF, CF14 7YT UK 585-453-4469 / 585-453-4152	KODAK AMERLIT PROGESTERONE ASSAY (LAN.0079/2079)	PROGESTERONE TEST SYSTME NRIA
20	PANTEX, DIV. BIO-ANALYSIS, INC. 1701 BERKELEY ST. SANTA MONICA, CA 90404 US 310-828-7423 / 310-828-7423	MULTIPLE	PROGESTERONE
21	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834	ENZYNUM-TEST, PROGESTERONE	PROGESTERONE TEST
22	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	ELECSYS PROGESTERONE	ELECTRO CHEMILUMNESCENCE ASSAY FOR DETERMINATION OF PROGESTERONE
23	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS PROGESTERONE ASSAY	PROGESTERONE ASSAY
24	SALIMETRICS LLC. 101 INNOVATION BLVD., STE. 302 STATE COLLEGE, PA 16803 US 814-234-7748 / 814-234-7748 207	SALIMETRICS SALIVARY PROGESTERONE ENZYME IMMUNOASSAY KIT	SALIVARY PROGESTERONE ENZYME IMMUNOASSAY KIT, PROGESTERONE TEST SYSTEM
25	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 PROGESTERONE	IMMUNOASSAY FOR MEASUREMENT OF PROGESTERONE
26	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS PROGESTERONE ASSAY	PROGESTERONE
27	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 PROGESTERONE	IMMUNOASSAY FOR MEASUREMENT OF PROGESTERONE
28	TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909	AIA-PACK PROG, ST AIA-PACK PROG	PROGESTERONE TEST SYSTEM
29	TOSOH BIOSCIENCE, INC. 3600 GANTZ ROAD GROVE CITY, OH 43123 US 813-542-75118 / 614-317-1909	AIA-PACK PROG, ST AIA-PACK PROG	PROGESTERONE TEST SYSTEM
30	TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909	AIA-PACK PROG, ST AIA-PACK PROG	PROGESTERONE TEST SYSTEM
31	TOSOH CORP. SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU TOKYO, 105-8623 JA 813-542-75118 / 614-317-1909	AIA-PACK PROGESTERONE (PROG) ASSAY	PROGESTERONE TEST SYSTEM
32	WALLAC OY MUSTIONKATU 6 TURKU, 20750 FI 781-663-6900 / 358-226-78111	AUTO DELFIA PROGESTERONE KIT	FLUOROIMMUNOASSAY FOR THE DETERMINATION OF PROGESTERONE