CORTISOL (HYDROCORTISONE AND HYDROXYCORTICOSTERONE) MANUFACTURED BY DRG INSTRUMENTS GMBH

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Request for Information Form	Contact Information
Company Name	DRG INSTRUMENTS GMBH
Address	FRAUENBERGSTRASSE 18
City, State, Zip	MARBURG,
Country	GM
FDA Owner/Operator Phone	908-233-2079
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	NHG
FDA Classification Name	ENZYME IMMUNOASSAY, CORTISOL, SALIVARY
FDA Device Classification Code	Standards
FDA Regulation Number	862.1205
FDA Common Generic Name	SALIVARY CORTISOL
FDA Proprietary Device Name	CORTISOL (HYDROCORTISONE AND HYDROXYCORTICOSTERONE)
FDA Owner / Operator Number	2245285
FDA Owner / Operator Name	DRG INTL., INC.
FDA Establishment Registration Number	3002800697
FDA Registered Establishment Name	DRG INSTRUMENTS GMBH
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	12-30-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	MONOBIND, INC. 100 N. POINTE DR. LAKE FOREST, CA 92630 US 949-951-2665 / 949-951-2665	ACCUBIND CORTISOL MICROWELL ELISA	CORTISOL ELISA
2	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS CORTISOL	CORTISOL TEST SYSTEM
3	SALIMETRICS LLC. 101 INNOVATION BLVD., STE. 302 STATE COLLEGE, PA 16803 US 814-234-7748 / 814-234-7748 207	HS SALIVARY CORTISOL ENZYME IMMUNOASSAY KIT	SALIVA CORTISOL EIA