VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT MANUFACTURED BY ORTHO-CLINICAL DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	ORTHO-CLINICAL DIAGNOSTICS
Address	FOREST FARM ESTATE WHITCHURCH
City, State, Zip	CARDIFF,
Country	UK
FDA Owner/Operator Phone	585-453-4469
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	LOL
FDA Classification Name	HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
FDA Device Classification Code	Standards
FDA Regulation Number	866.3310
FDA Common Generic Name	HEPATITIS A TEST
FDA Proprietary Device Name	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT
FDA Owner / Operator Number	9011934
FDA Owner / Operator Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Establishment Registration Number	9680658
FDA Registered Establishment Name	ORTHO-CLINICAL DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	09-18-06
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	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471	MULTIPLE: IMX HAVAB; IMX HAVAB-M	VARIOUS HEPATITIS A TESTS
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE: IMX HAVAB; IMX HAVAB-M	VARIOUS HEPATITIS A TESTS
3	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS HAV AB	HEPATITIS A TEST
4	BIOMERIEUX BV BOSEIND 15 BOXTEL, 5280 AB NL 33-478-872063 / 314-731-8594	MULTIPLE	HEPANOSTIKA ANTI-HAV MICROELISA SYSTEM
5	BIO-RAD ROUTE DE CASSEL STEENVOORDE, 59114 FR 331--4--795-6000 / 33-1-47956138	MONOLISA ANTI-HAV EIA, MONOLISA ANTI-HAV IGM EIA	ANTI-HAV EIA KIT, ANTI-HAV IGM EIA KIT
6	DIASORIN S.P.A. VIA CRESCENTINO SALUGGIA (VC), 13040 IT 390-161-487 093 / 651-351-5820	MULTIPLE	HEPATITIS A TEST KITS
7	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	HAV MULTIPLE DIAGNOSIS PRODUCTS	HAV MULTIPLE DIAGNOSIS PRODUCTS
8	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ADVIA CENTAUR ANTI HAV IGM	HEPATITIS A TEST