ROCHE DIAGNOSTICS CORP. - INDIANAPOLIS, IN

AA - Initial Distributor
MM - Manufacturer
MR - Remanufacturer
MS - Specification Developer
RR - Repackager/Relabeller
TD - Tentative Domestic Distributor

Establishment Status Code:

A - Active

Year of Most Recent Initial
or Annual Registration:

2007

FDA-Supplied Owner/Operator Information:

Owner/Operator Number:

1823260

Company Name:

ROCHE HOLDING, INC.

Address:

340 KINGSLAND ST.

Address 2:

City:

NUTLEY

State:

Zip / Postal Code:

07110

Country:

Owner/Operator Phone:

FDA-Supplied Official Correspondent Information:

Official Correspondent Name:

DR. ERIC KOLODZIEJ

Company Name:

ROCHE DIAGNOSTICS CORP.

Address:

9115 HAGUE ROAD

Address 2:

City:

INDIANAPOLIS

State:

Zip / Postal Code:

46250

Country:

Official Corespondent Phone Number:

317-521-2834

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 ROCHE DIAGNOSTICS CORP.
	Common Device Name	Proprietary Device Name
1	ACID KIT	ACID KIT
2	ADOLASE	NONE
3	AFP 200 ENZYMUN	AFP 200 ENZYMUN
4	APOLIPOPROTEIN	APOLIPOPROTEIN
5	BLOOD GLUCOSE MONITORS	ACCU-CHEK BLOOD GLUCOSE MONITORS
6	BLOOD GLUCOSE TESTING DEVICE	ACCU-CHEK ADVANTAGE H TEST STRIPS
7	CALIBRATION KIT	CALIBRATOR, SECONDARY
8	CEA ENZYMUN	CEA ENZYMUN
9	CHOLINESTERASE TABLETS	NONE
10	CLINICAL ANALYZER	ELECSYS 2010 ANALYZER
11	CONTROL SOLUTION	GLUCOSE CONTROL
12	ENZYNUM TEST, FSH	ENZYNUM TEST, FSH
13	ENZYNUM-TEST, IGE	ENZYNUM-TEST, IGE
14	ENZYNUM-TEST, LH	ENZYNUM-TEST, LH
15	ESTRADIOL TEST	ENZYNUM-TEST, ESTRADIOL
16	H. PYLORI TEST KIT	H. PYLORI TEST KIT
17	HCG	HUMAN CHORIONIC GONADOTROPIN
18	IGG KIT	IGG KIT
19	INFUSION SET	ACCU-CHEK ULTRAFLEX INFUSION SET
20	INSULIN ENZYMUN	INSULIN ENZYMUN
21	IRON AND IRON BINDING CAPACITY	IRON AND IRON BINDING CAPACITY
22	ISOKINETIC ARMBAND	SENSEWEAR ARMBAND
23	LACTATE TEST	ACCUSPORT PORTABLE ANALYZER AND LACTATE TEST STRIPS
24	LIPASE	LIPASE (U.V.) TURBIDMETRIC
25	MICROALBUMINARA NON-QUANTIFIED URINARY TEST	CHEMSTRIP MICRAL
26	NONE	NONE
27	PRECISET	PRECISET
28	PRESTAINED MICROSCOPE SLIDE	TESTSIMPLET
29	PROGESTERONE TEST	ENZYNUM-TEST, PROGESTERONE
30	PROTHROMBIN TIME AND ACTIVATED PARTIAL THROMBOPLASTIN TIME TESTS	MULTIPLE PRODUCT NAMES
31	QUALITATIVE DETECTION OF DRUGS METABOLITES IN URINE	ON TRAK TESTCUP PRO-S
32	REFLOTRON GOT	REFLOTRON GOT
33	SEROLOGICAL TEST	ROCHE SCRIPTS FOR COBAS AMPLICOR CT-NG TEST
34	SOFTWARE FOR DIABETES MANAGEMENT	DIABETES SOFTWARE
35	SYRINGE NEEDLE	ACCU-CHEK LINK ASSIST
36	TEST FOR DETERMINATIN OF LOW DESITY LIPOPROTEIN	COBAS INTEGRA LDL DIRECT
37	TINA QUANT C3	TINA QUANT C3
38	TINA QUANT C4	TINA QUANT C4
39	TINA QUANT RF	TINA QUANT RF
40	TOBRAMYCIN TEST SYSTEM	ONLINE TDM TOBRAMYCIN
41	TOTAL PROTEIN TEST	URINARY/CSF PROTEIN
42	TOTAL THYROXIDINE TEST	CEDIA T4
43	TOTAL TRIOIDDOTHYONINE TEST	ENZYNUM-TEST, T3
44	TRANSFERRIN (TINA QUANT)	TRANSFERRIN (TINA QUANT)
45	TRANSFERRIN TEST	TRANSFERRIN TEST
46	TROPONIN T TEST	CARDIAC T
47	VARIOUS ENZYME IMMUNOASSAY, PHENCYCLIDINE PRODUCTS	ONTRAK TEST CUPS
48	VARIOUS ENZYME IMMUNOASSAY, CANNABINOIDS PRODUCTS	MULTIPLE PRODUCT NAMES
49	VARIOUS DRUG MIXTURE CONTROL MATERIALS PRODUCTS	MULTIPLE PRODUCT NAMES
50	VARIOUS ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES PRODUCTS	MULTIPLE PRODUCT NAMES
51	VARIOUS FLUOROMETRY, MORPHINE PRODUCTS	MULTIPLE PRODUCT NAMES
All FDA-Registered products for this company are displayed above.

Other Products Offered by ROCHE DIAGNOSTICS CORP.:

No products have been listed by this company.

Services Offered by the ROCHE DIAGNOSTICS CORP.:
No services have been listed by this company.

Additional Contact Information for ROCHE DIAGNOSTICS CORP.:
There is no additional contact information for this company.

Competitors of ROCHE DIAGNOSTICS CORP.

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FDA-Registered Company Profile for ROCHE DIAGNOSTICS CORP.

FDA-Registered Products Offered by ROCHE DIAGNOSTICS CORP.

Other Products Offered by ROCHE DIAGNOSTICS CORP.:

Services Offered by the ROCHE DIAGNOSTICS CORP.:

Additional Contact Information for ROCHE DIAGNOSTICS CORP.:

Competitors of ROCHE DIAGNOSTICS CORP.