ACTIVE INHIBIN-A ELISA MANUFACTURED BY BECKMAN COULTER, INC.

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Request for Information Form	Contact Information
Company Name	BECKMAN COULTER, INC.
Address	445 MEDICAL CENTER BLVD.
City, State, Zip	WEBSTER, TX 77598
Country	US
FDA Owner/Operator Phone	714-871-4848
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	NDR
FDA Classification Name	ENZYME IMMUNOASSAY, INHIBIN-A
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1260
FDA Common Generic Name	INHIBIN-A
FDA Proprietary Device Name	ACTIVE INHIBIN-A ELISA
FDA Owner / Operator Number	2050012
FDA Owner / Operator Name	BECKMAN COULTER, INC.
FDA Establishment Registration Number	1628193
FDA Registered Establishment Name	BECKMAN COULTER, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	04-18-02
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	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS INHIBIN A	INHIBIN A
2	SALIMETRICS LLC. 101 INNOVATION BLVD., STE. 302 STATE COLLEGE, PA 16803 US 814-234-7748 / 814-234-7748 207	SALIMETRICS SALIVARY ESTRADIOL ENZYME IMMUNOASSAY KIT	SALIVARY ESTRADIOL ENZYME IMMUNOASSAY KIT