DIGENE HYBRID CAPTURE (R) II CT-ID TEST AND CT/GC TEST MANUFACTURED BY DIGENE CORP.

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Request for Information Form	Contact Information
Company Name	DIGENE CORP.
Address	1201 CLOPPER RD.
City, State, Zip	GAITHERSBURG, MD 20878
Country	US
FDA Owner/Operator Phone	301-944-7115
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	LSK
FDA Classification Name	DNA-REAGENTS, CHLAMYDIA
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3120
FDA Common Generic Name	REAGENTS FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS (CT) DNA
FDA Proprietary Device Name	DIGENE HYBRID CAPTURE (R) II CT-ID TEST AND CT/GC TEST
FDA Owner / Operator Number	9002668
FDA Owner / Operator Name	DIGENE CORP.
FDA Establishment Registration Number	1122376
FDA Registered Establishment Name	DIGENE CORP.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	09-12-00
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AMERITEK USA, INC. 125 130 ST. SE, #200 EVERETT, WA 98208 US 425-379-2580 / 425-379-2580	DBEST CHLAMYDIA TEST KIT	CHLAMYDIA TEST KIT
2	GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 US 858-410-8000 / 858-410-8891	PACE 2CHLAMYDIA TRACHOMATIS PROBE COMPETITION ASSAY	PACE 2CHLAMYDIA TRACHOMATIS PROBE COMPETITION ASSAY
3	IBL GMBH FLUGHAFENSTRASSE, 52A HAMBURG, D-22335 GM 49-40-53289122 / 715-294-1752	IBL CHLAMYDIA SEROLOGICAL REGENTS	IBL CHLAMYDIA SEROLOGICAL REGENTS