AIA-PACK CORT ST AIA-PACK CORT MANUFACTURED BY TOSOH BIOSCIENCE, INC.

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AIA-PACK CORT ST AIA-PACK CORT

Request for Information Form	Contact Information
Company Name	TOSOH BIOSCIENCE, INC.
Address	3600 GANTZ ROAD
City, State, Zip	GROVE CITY, OH 43123
Country	US
FDA Owner/Operator Phone	813-542-75118
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JFT
FDA Classification Name	FLUOROMETRIC, CORTISOL
FDA Device Classification Code	Standards
FDA Regulation Number	862.1205
FDA Common Generic Name	CORTISOL (HYDROCORTISONE AND HYDROXYCORTICOSTERONE) TEST SYSTEM
FDA Proprietary Device Name	AIA-PACK CORT ST AIA-PACK CORT
FDA Owner / Operator Number	8031673
FDA Owner / Operator Name	TOSOH CORP.
FDA Establishment Registration Number	3005529799
FDA Registered Establishment Name	TOSOH BIOSCIENCE, INC.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	10-24-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of TOSOH BIOSCIENCE, INC.

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	TDX CORTISOL	CORTISOL
2	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS CORTISOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	CORTISOL EIA
3	BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594	VIDAS CORTISOL ASSAY	ENZYME-LINKED FLUORESCENT IMMUNOASSAY, CORTISOL
4	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594	VIDAS CORTISOL ASSAY	ENZYME-LINKED FLUORESCENT IMMUNOASSAY, CORTISOL
5	FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645 US 412-490-8425 / 540-869-8163	ARCHITECT CORTISOL ASSAY	ARCHITECT CORTISOL ASSAY
6	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355 US / 610-240-3829	AXSYM CORTISOL	CORTISOL TEST SYSTEM
7	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	ARCHITECT CORTISOL ASSAY	ARCHITECT CORTISOL ASSAY
8	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS CORTISOL IMMUNOASSAY(MULTIPLE)	CORTISOL IMMUNOASSAY
9	TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909	AIA-PACK CORT, ST AIA-PACK CORT	IMMUNOASSAY, CORTISOL
10	TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909	AIA-PACK CORT, ST AIA-PACK CORT	IMMUNOASSAY, CORTISOL
11	TOSOH CORP. SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU TOKYO, 105-8623 JA 813-542-75118 / 614-317-1909	AIA-PACK CORT ASSAY	IMMUNOASSAY, CORTISOL