LIPASE (U.V.) TURBIDMETRIC MANUFACTURED BY ROCHE DIAGNOSTICS CORP.

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Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS CORP.
Address	9115 HAGUE RD.
City, State, Zip	INDIANAPOLIS, IN 46250
Country	US
FDA Owner/Operator Phone	--
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CET
FDA Classification Name	OLIVE OIL EMULSION (TURBIDIMETRIC), LIPASE
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1465
FDA Common Generic Name	LIPASE
FDA Proprietary Device Name	LIPASE (U.V.) TURBIDMETRIC
FDA Owner / Operator Number	1823260
FDA Owner / Operator Name	ROCHE HOLDING, INC.
FDA Establishment Registration Number	1823260
FDA Registered Establishment Name	ROCHE DIAGNOSTICS CORP.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	07-08-97
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	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	LIPASE SET	LIPASE SET
2	INTERNATIONAL BIO-ANALYTICAL INDUSTRIES, INC. 3595 NORTH DIXIE HWY., UNIT 5 BOCA RATON, FL 33431 US 561-826-0061 / 561-826-0061	LIPASE	LIPASE
3	NUCLIN DIAGNOSTICS, INC. 3322 COMMERCIAL AVE. NORTHBROOK, IL 60062 US 847-498-5210 / 847-498-5210	NUCLIPASE (RIA FOR HUMAN LIPASE)	RADIOIMMUNOASSAY FOR HUMAN PANCREATIC LIPASE
4	POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE CANTON, MI 48188 US 734-487-8300 / 734-487-8310		LIPASE
5	TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788	LIPASE REAGENT SET (COLIPASE METHOD)	LIPASE REAGENT SET (COLIPASE METHOD)