GENZYME ALPHA-AMYLASE TEST REAGENT MANUFACTURED BY GENZYME CORPORATION

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GENZYME ALPHA-AMYLASE TEST REAGENT

Request for Information Form	Contact Information
Company Name	GENZYME CORPORATION
Address	ONE KENDALL SQUARE
City, State, Zip	CAMBRIDGE, MA 02139
Country	US
FDA Owner/Operator Phone	617-252-7500
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CIJ
FDA Classification Name	SACCHAROGENIC, AMYLASE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1070
FDA Common Generic Name	REAGENT FOR ALPHA AMYLASE TEST
FDA Proprietary Device Name	GENZYME ALPHA-AMYLASE TEST REAGENT
FDA Owner / Operator Number	9002116
FDA Owner / Operator Name	GENZYME CORPORATION
FDA Establishment Registration Number	1221955
FDA Registered Establishment Name	GENZYME CORPORATION
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	02-16-95
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of GENZYME CORPORATION

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	ABAXIS, INC. 3240 WHIPPLE RD. UNION CITY, CA 94587 US 510-675-6500 / 510-675-6518	PICCOLO AMYLASE TEST SYSTEM	AMYLASE TEST SYSTEM
2	ARKRAY FACTORY INC. 1480 KOJI,KONAN-CHO, KOKA-SHI SHIGA,, 520-3306 JA 81-75-6628964 / 81-748-867298	SPOTCHEM II AMYLASE	AMYLASE
3	ARKRAY, INC. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU KYOTO, 601-8045 JA 81-75-6628964 / 81-748-867298	SPOTCHEM II AMYLASE	AMYLASE
4	CALDON BIOSCIENCE, INC. 2100 SOUTH RESERVOIR ST. POMONA, CA 91766 US 909-628-9944 / 909-628-9944	AMYLASE	AMYLASE
5	CALDON BIOTECH, INC. 2251 RUTHERFORD RD. CARLSBAD, CA 92008 US 760-804-7378 / 760-804-7378 305	AMYLASE	AMYLASE
6	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396	AMYLASE ASSAY KIT	AMYLASE ASSAY KIT
7	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
8	EQUAL DIAGNOSTICS, INC. 115 SUMMIT DR. EXTON, PA 19341 US 617-252-7500 / 617-768-6275	BIOTROL BILIRUBIN MONOREACTIF & ALPHA AMYLASE	BILIRUBIN (TOTAL AND DIRECT); ALPFA AMYLASE
9	GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 BREA, CA 92821 US 714-529-7125 / 714-529-7166	AMYLASE	AMYLASE REAGENT
10	INTERNATIONAL BIO-ANALYTICAL INDUSTRIES, INC. 3595 NORTH DIXIE HWY., UNIT 5 BOCA RATON, FL 33431 US 561-826-0061 / 561-826-0061	LIQUID AMYLASE (CNPG3)REAGENT SET	AMYLASE(CNPG3)
11	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688	OLYMPUS AMYLASE REAGENT	AMYLASE REAGENT
12	POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363	POLYMEDCO POLY-CHEM SYSTEM, AMYLASE	AMYLASE
13	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX AMYLASE (ETHYLIPENE PNPG7)	AMYLASE
14	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX AMYLASE (ETHYLIDENE PNPG7)	AMYLASE
15	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX AMYLASE (ETHYLIDENE PNPG7)	AMYLASE
16	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX AMYLASE (ETHYLIDENE PNPG7)	AMYLASE
17	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE