TAG-IT CYSTIC FIBROSIS KIT MANUFACTURED BY LUMINEX MOLECULAR DIAGNOSTICS, INC.

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Request for Information Form	Contact Information
Company Name	LUMINEX MOLECULAR DIAGNOSTICS, INC.
Address	439 UNIVERSITY AVE.
City, State, Zip	TORONTO, ONTARIO,
Country	CA
FDA Owner/Operator Phone	512-219-8020
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	NUA
FDA Classification Name	SYSTEM, CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, GENE MUTATION DETECTION
FDA Device Classification Code	Standards
FDA Regulation Number	866.5900
FDA Common Generic Name	CFTR GENE MUTATION DETECTION SYSTEM
FDA Proprietary Device Name	TAG-IT CYSTIC FIBROSIS KIT
FDA Owner / Operator Number	9032042
FDA Owner / Operator Name	LUMINEX CORP.
FDA Establishment Registration Number	3002777243
FDA Registered Establishment Name	LUMINEX MOLECULAR DIAGNOSTICS, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-23-06
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	CELERA 1401 HARBOR BAY PKWY ALAMEDA, CA 94502 US 203-840-2000 / 510-749-4389	CYSTIC FIBROSIS V3 GENOTYPING ASSAY	CF GENOTYPING ASSAY
2	CLINICAL MICRO SENSORS, INC. 757 SOUTH RAYMOND AVE. PASADENA, CA 91105 US 44- 07-8496027 / 626-463-2000 8523	ESENSOR (R) CYSTIC FIBROSIS CARRIER DETECTION SYSTEM	CYSTIC FIBROSIS CARRIER DETECTION SYSTEM