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FDA-Registered Company Profile for ORTHO-CLINICAL DIAGNOSTICS

FDA-Supplied Establishment Information:
Establishment Registration Number: 9680658
Company Name: ORTHO-CLINICAL DIAGNOSTICS
Address: FOREST FARM ESTATE WHITCHURCH (Map)
Address 2:
City: CARDIFF
State
Zip / Postal Code: CF14 7YT
County:
Country: UK
Establishment Operation Code(s): MM - Manufacturer
MS - Specification Developer
Establishment Status Code: A - Active
Year of Most Recent Initial
or Annual Registration:
2007
FDA-Supplied Owner/Operator Information:
Owner/Operator Number: 9011934
Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
Address: 100 INDIGO CREEK DR.
Address 2:
City: ROCHESTER
State: NY
Zip / Postal Code: 14626-5101
Country: US
Owner/Operator Phone: 585-453-4469
FDA-Supplied Official Correspondent Information:
Official Correspondent Name: MS. ANN QUINN
Company Name: ORTHO-CLINICAL DIAGNOSTICS
Address: 100 INDIGO CREEK DR.
Address 2:
City: ROCHESTER
State: NY
Zip / Postal Code: 14626 5101
Country: US
Official Corespondent Phone Number: 585-453-4152
FDA-Supplied US Agent Information:
US Agent Contact Name / Title: MS. ANN M. QUINN , REGULATORY AFFAIRS MANAGER
Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
Address: 100 INDIGO CREEK DR.
Address 2:
City: ROCHESTER
State: NY
Zip Code: 14626 5101
Country: US
US Agent Phone Number: 585-453-4152
US Agent Email Address: AQUINN2@OCDUS.JNJ.COM
Other Establishment Information:
Establishment Phone:
Fax:
General Email:
Web Site:
Company Brochure:
Keywords:
Company Description:
Services Offered:
About Us:
Differentiation:


FDA-Registered Products Offered by ORTHO-CLINICAL DIAGNOSTICS

Common Device Name Proprietary Device Name
1 AFP ASSAY VITROS IMMUNODIAGNOSTIC PRODUCTS AFP REAGENT PACK
2 ANTI HCV ASSAY VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS
3 B12-REAGENT MULTIPLE PRODUCT NAMES
4 CA 125 II ASSAY MULTIPLE PRODUCT NAMES
5 CA15-3 CALIBRATOR MULTIPLE PRODUCT NAMES
6 CALIBRATORS MULTIPLE PRODUCT NAMES
7 CEA ASSAY MULTIPLE PRODUCT NAMES
8 CKMB TEST SYSTEM VITROS IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENTS PACK
9 CONTROLS MULTIPLE PRODUCT NAMES
10 CONTROLS MULTIPLE PRODUCT NAMES
11 CORTISOL ASSAY VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK
12 ESTRADIOL TEST SYSTEM NRIA KODAK AMERLITE ESTRADIOL - 60 ASSAY (LAN.0081/2081)
13 FERRITIN TEST SYSTEM VITROS IMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PARK
14 FOLATE REAGENT MULTIPLE PRODUCT NAMES
15 FOLLICLE STIMULATING HORMONE TEST SYSTEM NRIA KODAK AMERLITE FSH ASSY (LAN.0077/2077)
16 FREE THYROXINE TESTSYSTEM NRIA KODAK AMERLITE MAB FREE T-4 ASSAY (LAN.0600/2600) & T-3 ASSAY (LAN.-0500/2500)
17 FREE TRIIODOTHYRONINE TEST SYSTEM VITROS IMMNODIAGNOSTIC PRODUCTS FREE T3 REAGENT
18 HBS AG CONTROLS VITROS IMMUNODIAGNOSTIC PRODUCTS HBS AG CONTROLS
19 HEPATITIS A TEST VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT
20 LUTEINIZING HORMONE TEST SYSTEM NRIA KODAK AMERLITE LH-30 ASSAY (LAN.0082/2082)
21 MYOGLOBIN ASSAY VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN ASSAY
22 NT-PROBNP TEST SYSTEM VITROS IMMUNODIAGNOSTIC PRODUCT NT-PROBNP REAGENT PACK
23 PROGESTERONE TEST SYSTME NRIA KODAK AMERLIT PROGESTERONE ASSAY (LAN.0079/2079)
24 PROGESTIRONE MULTIPLE PRODUCT NAMES
25 PROLACTIN TEST SYSTEM VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK
26 PSA ASSAY MULTIPLE PRODUCT NAMES
27 RUBELLA ASSAY VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG ASSAY
28 TESTOSTERONE CALIBRATORS VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE CALIBRATORS
29 THYROID STIMULATING HORMONE TEST SYSTEM (NRIA) KODAK AMERLITE TSH-30 ULTRASENSITIVE (LAN.0010/2010)
30 TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN ASSAY VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS
31 TOTAL B-HCG CALIBRATOR SYSTEM VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG CALIBRATOR
32 TOTAL B-HCG II ASSAY VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II ASSAY
33 TOTAL THYROXINE TEST SYSTEM & TOTAL TRIIODOTHYRONINE TEST SYSTEM NRIA KODAK AMERLITE TOTAL T-4 ASSAY (LAN.0002/2002) & T-3 ASSAY (LAN.2003/0003)
34 TRIIODOTHYRONINE UPTAKE TEST SYSTEM (NRIA) KODAK AMERLITE T-3 UPTAKE ASSAY (LAN.004/2004)
35 TROPONIN ASSAY MULTIPLE PRODUCT NAMES
36 VITROS CA 19-9 VITROS IMMUNODIAGNOSTIC PRODUCTS CA 19-9 REAGENT PACK
All FDA-Registered products for this company are displayed above.


Other Products Offered by ORTHO-CLINICAL DIAGNOSTICS:

 No products have been listed by this company.

Services Offered by the ORTHO-CLINICAL DIAGNOSTICS:

No services have been listed by this company.


Additional Contact Information for ORTHO-CLINICAL DIAGNOSTICS:

There is no additional contact information for this company.


Companies Related to ORTHO-CLINICAL DIAGNOSTICS

Our records indicate that the following companies are related by ownership.
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  Company Name Address City State Zip Country
1 ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER NY 14652 US
2 ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER NY 14652 US
3 ORTHO-CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. ROCHESTER NY 14626 US
4 ORTHO-CLINICAL DIAGNOSTICS, INC. 130 INDIGO CREEK DR., ROOM 350 ROCHESTER NY 14626 US


Competitors of ORTHO-CLINICAL DIAGNOSTICS

Our records indicate that the following companies may manufacture similar devices.
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Now Displaying Records 1 - 11 of 317

  Company Name Address City State Zip Country
1 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. (Map) CARLSBAD CA 92008 US
2 ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 (Map)
CRUCE DAVILA
BARCELONETA PR 00617 US
3 ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. (Map) ABBOTT PARK IL 60064 US
4 ABBOTT LABORATORIES 820 MISSION ST. (Map) SOUTH PASADENA CA 91030 US
5 ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE (Map) DES PLAINES IL 60018 US
6 ABBOTT POINT OF CARE CANADA LIMITED 436 HAZELDEAN ROAD (Map) KANATA, ONTARIO K2L 1T9 CA
7 ABBOTT POINT OF CARE CANADA LIMITED 185 CORKSTOWN ROAD (Map) NEPEAN, ONTARIO K2H 8V4 CA
8 ABBOTT POINT OF CARE INC. 104 WINDSOR CENTER DR. (Map) EAST WINDSOR NJ 08520 US
9 ABBOTT SMITH LABS, LLC 1485 N. PARK DR. (Map) WESTON FL 33326 US
10 ABON BIOPHARM (HANGZHOU) CO., LTD. HANGZHOU ECONOMIC & (Map)
TECHNOLOGICAL DEVELOPMENT AREA
HANGZHOU, ZHEJIANG 310018 CH







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