CYSTEINE MANUFACTURED BY ROCHE DIAGNOSTICS GMBH

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Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS GMBH
Address	SANDHOFER STRASSE 116
City, State, Zip	MANNHEIM,
Country	GM
FDA Owner/Operator Phone	49-621-7670
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JLC
FDA Classification Name	NITROPRUSSIDE REACTION (QUALITATIVE, URINE), CYSTINE
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1240
FDA Common Generic Name	CYSTEINE
FDA Proprietary Device Name	CYSTEINE
FDA Owner / Operator Number	9039767
FDA Owner / Operator Name	CORANGE DEUTSCHLAND HOLDING GMBH
FDA Establishment Registration Number	9610126
FDA Registered Establishment Name	ROCHE DIAGNOSTICS GMBH
FDA Operation Code(s)	AA - Initial Distributor
FDA Listing Date
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 companyies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	MISSION PHARMACAL CO. 1325 EAST DURANGO BLVD. SAN ANTONIO, TX 78210 US 800-292-7364 / 830-249-9822 4321	UROCYSTIN	QUALITATIVE SEMIQUANTITATIVE CYSTINE SYSTEM