CYSTIC FIBROSIS V3 GENOTYPING ASSAY MANUFACTURED BY CELERA

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Request for Information Form	Contact Information
Company Name	CELERA
Address	1401 HARBOR BAY PKWY
City, State, Zip	ALAMEDA, CA 94502
Country	US
FDA Owner/Operator Phone	203-840-2000
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	CF GENOTYPING ASSAY
FDA Proprietary Device Name	CYSTIC FIBROSIS V3 GENOTYPING ASSAY
FDA Owner / Operator Number	9023722
FDA Owner / Operator Name	APPLERA CORP.
FDA Establishment Registration Number	3004008801
FDA Registered Establishment Name	CELERA
FDA Operation Code(s)
FDA Listing Date	06-08-06
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	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
2	LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. TORONTO, ONTARIO, M5G 1Y8 CA 512-219-8020 / 512-381-3296	TAG-IT CYSTIC FIBROSIS KIT	CFTR GENE MUTATION DETECTION SYSTEM