ORTHO-CLINICAL DIAGNOSTICS, INC.

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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.

Address 2:

City:

ROCHESTER

State

Zip / Postal Code:

14652-3104

County:

MONROE

Country:

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:

Zip / Postal Code:

14626-5101

Country:

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:

Zip / Postal Code:

14626 5101

Country:

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	C-REACTIVE PROTEIN ASSAY	VITROS CHEMISTRY PRODUCTS HSCRP REAGENT
11	C-REACTIVE PROTEIN ASSAY	VITROS CHEMISTRY PRODUCTS HSCRP REAGENT
12	CALIBRATOR	VITROS CHEMISTRY PRODUCTS CALIBRATOR KITS (MULTIPLE)
13	CALIBRATORS	VITROS CHEMISTRY PRODUCTS CALIBRATOR KITS (MULTIPLE)
14	CALIBRATORS	VITROS CHEMISTRY PRODUCTS CALIBRATOR KITS (MULTIPLE)
15	CALIBRATORS, DRUG MIXTURE	MULTIPLE PRODUCT NAMES
16	CANNABINOID METABOLITES ASSAY	VITROS CHEMISTRY PRODUCTS THC REAGENT
17	CHOLESTEROL (TOTAL) TEST SYSTEM	VITROS CHEMISTRY PRODUCTS DT HDL CHOLESTEROL KIT
18	CLINICAL TOXICOLOGY CALIBRATOR	VITROS CHEMISTRY PRODUCTS CALIBRATOR KITS 11, 12, 13, 14
19	COCAINE METABOLITE ASSAY	VITROS CHEMISTRY PRODUCTS COCM REAGENT
20	COMPLEMENT C3 ASSAY	VITROS CHEMISTRY PRODUCTS C3 REAGENT
21	COMPLEMENT C4 ASSAY	VITROS CHEMISTRY PRODUCTS C4 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.

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

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

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

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

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

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