ACS PHENYTOIN ASSAY MANUFACTURED BY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Address	511 BENEDICT AVENUE
City, State, Zip	TARRYTOWN, NY 10591
Country	US
FDA Owner/Operator Phone	914-524-2955
FDA Medical Specialty Code	TX - Clinical Toxicology
FDA Product Code	LGR
FDA Classification Name	FLUORESCENCE POLARIZATION IMMUNOASSAY, DIPHENYLHYDANTOIN (TOTAL)
FDA Device Classification Code	Standards
FDA Regulation Number	862.3350
FDA Common Generic Name	ACS PHENYTOIN ASSAY
FDA Proprietary Device Name	ACS PHENYTOIN ASSAY
FDA Owner / Operator Number	9096044
FDA Owner / Operator Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Establishment Registration Number	2432235
FDA Registered Establishment Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	05-08-02
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	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS ASSAYS FOR DETECTION OF PHENYTOIN
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS ASSAYS FOR DETECTION OF PHENYTOIN
3	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	INNOFLUOR PHENYTOIN ASSAY S. MULTIPLE DIAGNOSIS PRODUCTS	INNOFLUOR PHENYTOIN ASSAY S. MULTIPLE DIAGNOSIS PRODUCTS
4	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	INNOFLUOR PHENYTOIN REAGENT SET	PHENYTOIN REAGENT SET
5	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS PHENYTOIN ASSAY	ACS PHENYTOIN ASSAY