DBEST CHLAMYDIA TEST KIT MANUFACTURED BY AMERITEK USA, INC.

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Request for Information Form	Contact Information
Company Name	AMERITEK USA, INC.
Address	125 130 ST. SE, #200
City, State, Zip	EVERETT, WA 98208
Country	US
FDA Owner/Operator Phone	425-379-2580
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	CHLAMYDIA TEST KIT
FDA Proprietary Device Name	DBEST CHLAMYDIA TEST KIT
FDA Owner / Operator Number	9002732
FDA Owner / Operator Name	AMERITEK USA, INC.
FDA Establishment Registration Number	3025672
FDA Registered Establishment Name	AMERITEK USA, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	09-04-00
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	DIGENE CORP. 1201 CLOPPER RD. GAITHERSBURG, MD 20878 US 301-944-7115 / 301-944-7259	DIGENE HYBRID CAPTURE (R) II CT-ID TEST AND CT/GC TEST	REAGENTS FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS (CT) DNA
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