IBL AMERICA 17-HYDROXYPROGESTERONE ELISA TEST KIT MANUFACTURED BY DEMEDITEC DIAGNOSTICS

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IBL AMERICA 17-HYDROXYPROGESTERONE ELISA TEST 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	JLX
FDA Classification Name	RADIOIMMUNOASSAY, 17-HYDROXYPROGESTERONE
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1395
FDA Common Generic Name	IBL AMERICA 17-HYDROXYPROGESTERONE ELISA TEST KIT
FDA Proprietary Device Name	IBL AMERICA 17-HYDROXYPROGESTERONE ELISA TEST 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	04-26-06
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	BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	VARIOUS
2	DRG INSTRUMENTS GMBH FRAUENBERGSTRASSE 18 MARBURG, D-35039 GM 908-233-2079 / 908-233-2079	17-HYDROXYPROGESTERONE TEST SYSTEM	17-OH PROGESTERONE
3	DRG INTL., INC. 1167 US HIGHWAY 22 MOUNTAINSIDE, NJ 07092 US 908-233-2079 / 908-233-2075	DRG AURICA 17- AOH PROGESTERONE ELISA TEST	AOH PROGESTERONE ELISA KIT, EIA1561
4	IBL GMBH FLUGHAFENSTRASSE, 52A HAMBURG, D-22335 GM 49-40-53289122 / 715-294-1752	IBL 17-HYDROXYPROGESTERONE ELISA TEST KIT	IBL 17-HYDROXYPROGESTERONE ELISA TEST KIT
5	IBL MEDIKAL URUNLER SANAYI VE TICARET LTD. STI IVEDIK ORGANIZE SANAYI BOLGESI 21 CAD. 517 SOK. NO: 2 YENIMAHALLE/ANKARA, 06370 TU 09-312-395 7007 / 763-780-2955	IBL 17-OH PROGESTERONE ELISA TEST KIT	17-OH PROGESTERONE ELISA
6	LABOR DIAGNOSTIKA NORD GMBH & CO. KG AM EICHENHAIN 1 NORDHORN, 48531 GM 49-592-1855105 / 49-592-172728105	MULTIPLE	17-HYDROXYPROGESTERONE ELISA
7	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	NEOSCREEN ELISA HYDROXY PROGESTERONE	VARIOUS
8	NEO-GENESIS, A DIVISION OF NATUS 15410 SE 82ND DR. SUITE 270 CLACKAMAS, OR 97015 US 503-657-8000 / 503-657-8000	ACCUSCREEN 17-OHP	17-OHP TEST SYSTEM
9	NEOMETRICS, A DIVISION OF NATUS 104 BELLEROSE AVE. EAST NORTHPORT, NY 11731 US 516-754-8080 / 516-754-8080	ACCUSCREEN 17P
10	PANTEX, DIV. BIO-ANALYSIS, INC. 1701 BERKELEY ST. SANTA MONICA, CA 90404 US 310-828-7423 / 310-828-7423	MULTIPLE	17-HYDROXYPROGESTERONE
11	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	COAT-A COUNT 17A-OH PROGESTERONE	RIA FOR THE MEASUREMENT OF 17-ALPHA-OH PROGESTERONE
12	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	COAT-A-COUNT 17A-OH PROGESTERONE	RIA FOR THE MEASUREMENT OF 17-ALPHA-OH PROGESTERONE
13	WALLAC OY MUSTIONKATU 6 TURKU, 20750 FI 781-663-6900 / 358-226-78111	AUTO DELFIA NEONATAL 17-OH-PROGESTERONE KIT	FLUOROIMMUNOASSAY FOR THE DETERMINATION OF 17-HYDROXYPROGESTERONE