ORTHO-CLINICAL DIAGNOSTICS, INC.

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

FDA-Supplied Establishment Information:

Establishment Registration Number:

1319809

Company Name:

ORTHO-CLINICAL DIAGNOSTICS, INC.

Address:

300 WEILAND RD.

Address 2:

City:

ROCHESTER

State

Zip / Postal Code:

14652-6307

County:

MONROE

Country:

Establishment Operation Code(s):

ME - Contract Manufacturer
MM - Manufacturer

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:

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	ACETAMINOPHEN TEST SYSTEM	VITROS CHEMISTRY PRODUCTS ACETAMINOPHEN SLIDE
2	ACID PHOSPHATASE CHEMISTRY SLIDE	VITROS CHEMISTRY PRODUCTS ACP SLIDES
3	ALANINE AMINO TRANSFERASE (ALT/SGPT) TEST SYSTEM	MULTIPLE PRODUCT NAMES
4	ALBUMIN TEST SYSTEM	MULTIPLE PRODUCT NAMES
5	ALCOHOL TEST SYSTEM	VITROS CHEMISTRY PRODUCTS ALC SLIDES
6	ALKALINE PHOSPHATASE TEST SYSTEM	MULTIPLE PRODUCT NAMES
7	AMMONIA TEST SYSTEM	VITROS CHEMISTRY PRODUCTS AMON SLIDES
8	AMYLASE TEST SYSTEM	MULTIPLE PRODUCT NAMES
9	ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM	MULTIPLE PRODUCT NAMES
10	BICARBONATE/CARBON DIOXIDE TEST SYSTEM	MULTIPLE PRODUCT NAMES
11	BILIRUBIN (TOTAL OR DIRECT) TEST SYSTEM	VITROS CHEMISTRY PRODUCTS TBIL SLIDES
12	C-REACTIVE PROTEIN TEST	VITROS CHEMISTRY PRODUCTS CRP SLIDE
13	CALCIUM TEST SYSTEM	MULTIPLE PRODUCT NAMES
14	CARBAMAZEPINE ASSAY	VITORS CHEMISTRY PRODUCTS CRBM
15	CARBON DIOXIDE TEST SYSTEM	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CO2)
16	CHLORIDE TEST SYSTEM	MULTIPLE PRODUCT NAMES
17	CHOLESTEROL (TOTAL) TEST SYSTEM	MULTIPLE PRODUCT NAMES
18	CHOLINESTERASE TEST SYSTEM	MULTIPLE PRODUCT NAMES
19	CREATINE PHOSPHOKINASE/CREATINE KINASE TEST SYSTEM	MULTIPLE PRODUCT NAMES
20	CREATININE TEST SYSTEM	MULTIPLE PRODUCT NAMES
21	DIGOXIN TEST SYSTEM	VITROS CHEMISTRY PRODUCTS DGXN SLIDES
22	DIPHENYLHYDANTOIN TEST SYSTEM	VITROS CHEMISTRY PRODUCTS PHYT SLIDES
23	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE	MULTIPLE PRODUCT NAMES
24	GAMMA-GLUTAMYL TRANSPEPTIDASE	MULTIPLE PRODUCT NAMES
25	GLUCOSE TEST SYSTEM	MULTIPLE PRODUCT NAMES
26	IRON (NON-HEME) TEST SYSTEM	VITROS CHEMISTRY PRODUCTS FE SLIDES
27	LACTATE DEHYDROGENASE TEST SYSTEM	MULTIPLE PRODUCT NAMES
28	LACTIC ACID TEST SYSTEM	MULTIPLE PRODUCT NAMES
29	LIPASE TEST SYSTEM	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LIPA)
30	LIPASE TEST SYSTEM	MULTIPLE PRODUCT NAMES
31	LIPOPROTEIN TEST SYSTEM	VITROS CHEMISTRY PRODUCTS DHDL SLIDES
32	LITHIUM TEST SYSTEM	MULTIPLE PRODUCT NAMES
33	MAGNESIUM TEST SYSTEM	MULTIPLE PRODUCT NAMES
34	PHENOBARBITAL ASSAY	VITROS CHEMISTRY PRODUCTS PHBR SLIDES
35	PHOSPHORUS (INORGANIC) TEST SYSTEM	MULTIPLE PRODUCT NAMES
36	POTASSIUM TEST SYSTEM	MULTIPLE PRODUCT NAMES
37	SALICYLATE TEST SYSTEM	VITROS CHEMISTRY PRODUCTS SALI SLIDES
38	SODIUM TEST SYSTEM	MULTIPLE PRODUCT NAMES
39	THEOPHYLLINE TEST SYSTEM	MULTIPLE PRODUCT NAMES
40	TOTAL PROTEIN TEST SYSTEM	MULTIPLE PRODUCT NAMES
41	TOTAL PROTEIN TEST SYSTEM	VITROS CHEMISTRY PRODUCTS UPRO SLIDES
42	UREA NITROGEN TEST SYSTEM	VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES
43	URIC ACID TEST SYSTEM	MULTIPLE PRODUCT NAMES
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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