VITROS CHEMISTRY PRODUCTS AAT REAGENT MANUFACTURED BY ORTHO-CLINICAL DIAGNOSTICS, INC.

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VITROS CHEMISTRY PRODUCTS AAT REAGENT

Request for Information Form	Contact Information
Company Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
Address	601 LEE RD.
City, State, Zip	ROCHESTER, NY 14652
Country	US
FDA Owner/Operator Phone	585-453-4469
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	DEM
FDA Classification Name	ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5130
FDA Common Generic Name	AAT REAGENT
FDA Proprietary Device Name	VITROS CHEMISTRY PRODUCTS AAT REAGENT
FDA Owner / Operator Number	9011934
FDA Owner / Operator Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Establishment Registration Number	1319808
FDA Registered Establishment Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	01-03-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ORTHO-CLINICAL DIAGNOSTICS, INC.

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	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	ALPHA-1-ANTITRYPSIN
2	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	QUANTIPLATE OR ENDOPLATE TM ALPHA-1-ANTITRYPSIN SINGLE RADIA	ALPHA-1-ANTITRYPSIN SINGLE RADIAL IMMUNODIFFUSION KIT
3	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	ALPHA-1-ANTITRYPSIN
4	BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000	MULTIPLE (QUANTIA A1-AT)	A1-AT TURBIDIMETRY TEST
5	COVANCE RESEARCH PRODUCTS, INC. 180 RUSTCRAFT RD., SUITE 140 DEDHAM, MA 02026 US 800-922-2226 / 781-915-1405	ALPHA 1 ANTITRYPSIN, POLYCLONAL ANTIBODY	AAT, POLYCLONAL ANTIBODY
6	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	ANTISERUM TO HUMAN ANTITRYPSIN	ANTISERUM TO HUMAN ANTITRYPSIN
7	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
8	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	MULTIPLE	ANTI-HUMAN ALPHA-1-ANTITRYPSIN ANYSERA IGG FRACTION AND NEPHELOMETRIC;TURBIMETRI
9	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	ALPHA-1 ANTITRYPSIN IMMUNOL MULTIPLE DIAGNOSIS	ALPHA-1 ANTITRYPSIN IMMUNOL MULTIPLE DIAGNOSIS
10	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL	ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL
11	KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068	K-ASSAY ALPHA-1 ANTITRYSPIN IMMUNOTURBIDIMETRIC ASSAY	ALPHA-1 ANTITRYPSIN IMMUNOTURBIDIMETRIC
12	KENT LABORATORIES, INC. 777 JORGENSEN PLACE BELLINGHAM, WA 98226 US 360-398-8641 / 360-398-8641	ALPHA-1-ANTITRYPSIN RADIAL IMMUNODIFFUSION KIT	ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL TEST SYSTEM
13	NITTO BOSEKI CO., LTD. (MEDICAL DIVISION) 4-1-28 KUDAN-KITA CHIYODA-KU TOKYO, 102-0073 JA 81-3-32384540 / 206-575-8068	N-ASSAY TIA ALPHA-1-AT-H	ALPHA-1 ANTI-TRYPSIN ITA
14	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688	OLYMPUS ALPHA-1-ANTITRYPSIN REAGENT	ALPHA-1-ANTITRYPSIN REAGENT
15	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	TINA-QUANT 2-1-ANTITRYPSIN ASSAY	IMMUNOTURBIDIMETRIC ASSAY FOR THE DETERMINATION OF 2-1 ANTITRYPSIN
16	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
17	THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000	HUMAN ALPHA-1 ANTITRYPSIN BINDARID RADICAL IMMUNODIFFUSION KIT	ALPHA 1 ANTITRYPSIN RID KIT
18	THE BINDING SITE, INC. 5889 OBERLIN DR., SUITE 101 SAN DIEGO, CA 92121 US 858-453-9177 / 858-453-9177		IMMUNOLOGICAL TEST SYSTEM
19	VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. TUCSON, AZ 85755 US 520-887-2155 / 520-229-3928	MULTIPLE	VARIOUS ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL TEST SYSTEMS