CHLAMYDIA OIA MANUFACTURED BY IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS

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CHLAMYDIA OIA

Request for Information Form	Contact Information
Company Name	IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS
Address	331 SOUTH 104TH ST.
City, State, Zip	LOUISVILLE, CO 80027
Country	US
FDA Owner/Operator Phone	781-674-3900
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	LJC
FDA Classification Name	ENZYME LINKED IMMUNOABSORBENT ASSAY, (CHLAMYDIAE GROUP)
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3120
FDA Common Generic Name	CHLAMYDIA ANTIGEN QUALITATIVE DETECTION KIT
FDA Proprietary Device Name	CHLAMYDIA OIA
FDA Owner / Operator Number	9006731
FDA Owner / Operator Name	INVERNESS MEDICAL INNOVATIONS, INC.
FDA Establishment Registration Number	1720655
FDA Registered Establishment Name	IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	01-08-96
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS

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	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS ASSAYS TO DETECT CHLAMYDIA TRACHOMATIS
2	APPLIED BIOTECH 10237 FLANDERS CT. SAN DIEGO, CA 92121 US 781-674-3900 / 858-587-6771	MULTIPLE	VARIOUS
3	BACTUS AB LUNASTIGEN 3 HUDDINGE, SE-141 44 SW 468-608-8630 / 468-608-8632	PHADEBACT CHLAMYDIA EIA	CHLAMYDIA TEST
4	BERKLEY INDUSTRIES, LLC 14450 INDUSTRY CIR. LA MIRADA, CA 90638 US 714-670-4274 / 714-522-5400 4274	QUICKVUE CHLAMYDIA TEST	IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF CHLAMYDIA FROM CLINICAL SPECIMENS
5	BIO-MEDICAL PRODUCTS CORP. 10 HALSTEAD RD. MENDHAM, NJ 07945 US 973-543-7434 / 973-543-7434
6	BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594	VIDAS CHLAMYDIA & CHLAMYDIA BLOCKING ASSAYS	ENZYME LINKED IMMUNOABSORBENT ASSAY, (EIFA) CHLAMYDIA ANTIGEN DETECTION ASSAY
7	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594	VIDAS CHLAMYDIA & CHLAMYDIA BLOCKING ASSAYS	ENZYME LINKED IMMUNOABSORBENT ASSAY, (EIFA) CHLAMYDIA ANTIGEN DETECTION ASSAY
8	BIO-RAD LABORATORIES, INC. 1000 THOMAS ST. SEATTLE, WA 98109 US 425-881-8300 / 425-498-1709	MULTIPLE	VARIOUS CHLAMYDIA EIA KITS
9	DEXALL BIOMEDICAL LABS, INC. 18904 BONANZA WAY GAITHERSBURG, MD 20879 US / 301-840-1884	VIRODEX, ACTI.TIP, RAPID, SIMULTRAC	ENZYME IMMUNOASSAY TO IGA/IGC ANTIBODIES TO CHLAMYDIA TRACHOMATIS
10	DIAGNOSTIC AUTOMATION, INC. 23961 CRAFTSMAN RD. SUITE D/E/F CALABASAS, CA 91302 US 818-591-3030 / 818-591-3030	ENZYME LINKED IMMUNOABSORBENT ASSAY (CHLAMYDIAE GROUP)	ENZYME LINKED IMMUNOABSORBENT ASSAY (CHLAMYDIAE GROUP)
11	GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 US 858-410-8000 / 858-410-8891	PACE 2C SYSTEM	CHLAMYDIA TRACHOMATIS & NEISSERIA GONORRHOEAE
12	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 2 RESEARCH WAY PRINCETON, NJ 08540 US 781-674-3900 / 609-627-8038	CHLAMYDELSIA II EIA TEST	CHLAMYDIA IGG ENZYME LINKED IMMUNOABSORBENT ASSAY TEST KIT
13	MAST DIAGNOSTICA LABORATORIUMS-PRAPARATE GMBH FELDSTRASSE 20 REINFELD, D-23858 GM 494-533-20070 / 763-780-2955	MASTAZYME CHLAMYDIA	CHLAMYDIA ANTIGEN ASSAY
14	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	MULTIPLE CHLAMYDIA KITS	VARIOUS
15	OXOID (ELY) LIMITED DENMARK HOUSE ELY, CAMBRIDGESHIRE, CB7 4ET UK 412-490-8425 / 441-353-646200	IDEIA CHLAMYDIA PCE BLOCKING TEST, IDEIA PCE CHLAMYDIA,	CHLAMYDIA BLOCKING REAGENTS, CHLAMYDIA TEST KIT
16	SAVYON DIAGNOSTICS, LTD. 3 HABOSEM ST. ASHDOD, 77101 IS 972-885-62920 / 972-885-62920 x242	MULTIPLE	CHLAMYDIA EIA TEST KIT
17	ST. PAUL BIOTECH 11555 MONARCH ST. GARDEN GROVE, CA 92841 US 714-903-1000 / 714-903-1000 226	MULTIPLE	CHLAMYDIA TEST
18	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851	MULTIPLE	VARIOUS CHLAMYDIA TESTS
19	TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800	MULTIPLE	VARIOUS
20	UNIPATH LTD. PRIORY BUSINESS PARK BEDFORD, MK44 3UP UK 781-674-3900 / 441-234-835564	NO PROPRIETARY NAME LISTED	TEST KIT FOR THE DETECTION OF CHLAMYDIAL ANTIGEN FROM ENDOCERVICAL

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