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FDA-Registered Company Profile for ORTHO-CLINICAL DIAGNOSTICS, INC.

FDA-Supplied Establishment Information:
Establishment Registration Number: 1319808
Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
Address: 601 LEE RD. (Map)
Address 2:
City: ROCHESTER
State NY
Zip / Postal Code: 14652-3104
County: MONROE
Country: US
Establishment Operation Code(s): MM - Manufacturer
MS - Specification Developer
RR - Repackager/Relabeller
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: MR. NEIL GREENBERG
Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
Address: 100 INDIGO CREEK DR.
Address 2:
City: ROCHESTER
State: NY
Zip / Postal Code: 14626 5101
Country: US
Official Corespondent Phone Number: 585-453-3768
Other Establishment Information:
Establishment Phone:
Fax:
General Email:
Web Site: http://www.orthoclinical.com
Company Brochure:
Keywords:
Company Description:
Services Offered:
About Us:
Differentiation:


FDA-Registered Products Offered by ORTHO-CLINICAL DIAGNOSTICS, INC.

Common Device Name Proprietary Device Name
1 AAT REAGENT VITROS CHEMISTRY PRODUCTS AAT REAGENT
2 ALBUMIN ASSAY VITROS CHEMISTRY PRODUCTS MALB REAGENT
3 ALCOHOL CALIBRATOR MULTIPLE PRODUCT NAMES
4 AMPHETAMINE TEST SYSTEM VITROS CHEMISTRY PRODUCTS AMPH REAGENT
5 ANTISTREPTOLYSIN O REAGENT VITROS CHEMISTRY PRODUCTS ASO REAGENT
6 APOLIPOPROTEIN A1 (APOA1), APOLIPOPROTEIN B (APOB) ASSAYS VITROS CHEMISTRY PRODUCTS APOA1, APOB REAGENTS
7 BARBITURATES ASSAY VITROS CHEMISTRY PRODUCTS BARB REAGENT
8 BENZODIAZIPINE ASSAY VITROS CHEMISTRY PRODUCTS BENZ REAGENT
9 BLOOD CELL DILUENT VITROS CHEMISTRY PRODUCTS SPECIALTY DILUENT
10 CALIBRATOR VITROS CHEMISTRY PRODUCTS CALIBRATOR KITS (MULTIPLE)
11 CALIBRATORS VITROS CHEMISTRY PRODUCTS CALIBRATOR KITS (MULTIPLE)
12 CALIBRATORS VITROS CHEMISTRY PRODUCTS CALIBRATOR KITS (MULTIPLE)
13 CALIBRATORS, DRUG MIXTURE MULTIPLE PRODUCT NAMES
14 CANNABINOID METABOLITES ASSAY VITROS CHEMISTRY PRODUCTS THC REAGENT
15 CHOLESTEROL (TOTAL) TEST SYSTEM VITROS CHEMISTRY PRODUCTS DT HDL CHOLESTEROL KIT
16 CLINICAL TOXICOLOGY CALIBRATOR VITROS CHEMISTRY PRODUCTS CALIBRATOR KITS 11, 12, 13, 14
17 COCAINE METABOLITE ASSAY VITROS CHEMISTRY PRODUCTS COCM REAGENT
18 COMPLEMENT C3 ASSAY VITROS CHEMISTRY PRODUCTS C3 REAGENT
19 COMPLEMENT C4 ASSAY VITROS CHEMISTRY PRODUCTS C4 REAGENT
20 C-REACTIVE PROTEIN ASSAY VITROS CHEMISTRY PRODUCTS HSCRP REAGENT
21 C-REACTIVE PROTEIN ASSAY VITROS CHEMISTRY PRODUCTS HSCRP REAGENT
22 DIRECT LDL ASSAY VITROS CHEMISTRY PRODUCTS DLDL REAGENT
23 DRUG SPECIFIC CONTROL MATERIAL MULTIPLE PRODUCT NAMES
24 GENERAL PURPOSE REAGENT VITROS CHEMISTRY PRODUCTS CITRIC ACID SOLUTION
25 GENERAL PURPOSE REAGENTS MULTIPLE PRODUCT NAMES
26 GENTAMICIN (GENT) ASSAY VITROS CHEMISTRY PRODUCTS GENT REAGENT
27 GLYCOCHEMOGLOBIN ASSAY VITROS CHEMISTRY PRODUCTS %A1C REAGENT KIT
28 HAPTOGLOBIN ASSAY VITROS CHEMISTRY PRODUCTS HPT REAGENT
29 HOMOCYSTINE TEST SYSTEMS VITROS CHEMISTRY PRODUCTS HCY REAGENT
30 IMMUNOGLOBULIN G (IGG), M (IGM), A (IGA) ASSAYS VITROS CHEMISTRY PRODUCTS IGA, IGG, IGM REAGENTS
31 IRON-BINDING CAPACITY TEST SYSTEM MULTIPLE PRODUCT NAMES
32 LIPOPROTEIN TEST SYSTEMS VITROS CHEMISTRY PRODUCTS MAGNETIC HDL CHOLESTEROL, DHDL REAGENTS
33 METHADONE TEST SYSTEM VITROS CHEMISTRY PRODUCTS METD REAGENT
34 PHENCYCLIDINE TEST SYSTEM VITROS CHEMISTRY PRODUCTS PCP REAGENT
35 PREALBUMIN ASSAY VITROS CHEMISTRY PRODUCTS PALB REAGENT
36 QUALITY CONTROL MATERIAL MULTIPLE PRODUCT NAMES
37 QUALITY CONTROL MATERIAL VITROS CHEMISTRY PRODUCTS PERFORMANCE VERIFIERS (MULTIPLE)
38 QUALITY CONTROL MATERIAL VITROS CHEMISTRY PRODUCTS PERFORMANCE VERIFIERS (MULTIPLE)
39 RED-CELL LYSING REAGENT VITROS CHEMISTRY PRODUCTS HEMOLYZING REAGENT
40 RHEUMATOID FACTOR ASSAY VITROS CHEMISTRY PRODUCTS RF REAGENT
41 THEOPHYLLINE TEST SYSTEM VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT
42 TOBRAMYCIN (TOBRA) ASSAY VITROS CHEMISTRY PRODUCTS TOBRA REAGENT
43 TRANSFERRIN ASSAY VITROS CHEMISTRY PRODUCTS TRFRN REAGENT
44 VALPROIC ACID (VALP) ASSAY VITROS CHEMISTRY PRODUCTS (VALP) REAGENT
45 VANCOMYCIN (VANC) ASSAY VITROS CHEMISTRY PRODUCTS VANC REAGENT
46 VITROS OP REAGENT VITROS CHEMISTRY PRODUCTS OP REAGENT
All FDA-Registered products for this company are displayed above.


Other Products Offered by ORTHO-CLINICAL DIAGNOSTICS, INC.:

 No products have been listed by this company.

Services Offered by the ORTHO-CLINICAL DIAGNOSTICS, INC.:

No services have been listed by this company.


Additional Contact Information for ORTHO-CLINICAL DIAGNOSTICS, INC.:

There is no additional contact information for this company.


Companies Related to ORTHO-CLINICAL DIAGNOSTICS, INC.

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 FOREST FARM ESTATE WHITCHURCH CARDIFF CF14 7YT UK
2 ORTHO-CLINICAL DIAGNOSTICS, INC. 130 INDIGO CREEK DR., ROOM 350 ROCHESTER NY 14626 US
3 ORTHO-CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. ROCHESTER NY 14626 US
4 ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER NY 14652 US


Competitors of ORTHO-CLINICAL DIAGNOSTICS, INC.

Our records indicate that the following companies may manufacture similar devices.
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