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FDA-Registered Company Profile for ROCHE DIAGNOSTICS CORP.

FDA-Supplied Establishment Information:
Establishment Registration Number: 1823260
Company Name: ROCHE DIAGNOSTICS CORP.
Also Known As: ROCHE DIAGNOSTICS GMBH
ROCHE DIAGNOSTIC SYSTEMS, INC.
ROCHE MOLECULAR BIOCHEMICALS
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE DIAGNOSTICS OPERATIONS
Address: 9115 HAGUE RD.
Address 2:
City: INDIANAPOLIS
State IN
Zip / Postal Code: 46250
County: MARION
Country: US
Establishment Operation Code(s): 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: NJ
Zip / Postal Code: 07110
Country: US
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: IN
Zip / Postal Code: 46250
Country: US
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, COCAINE AND COCAINE METABOLITES PRODUCTS MULTIPLE PRODUCT NAMES
48 VARIOUS FLUOROMETRY, MORPHINE PRODUCTS MULTIPLE PRODUCT NAMES
49 VARIOUS ENZYME IMMUNOASSAY, PHENCYCLIDINE PRODUCTS ONTRAK TEST CUPS
50 VARIOUS ENZYME IMMUNOASSAY, CANNABINOIDS PRODUCTS MULTIPLE PRODUCT NAMES
51 VARIOUS DRUG MIXTURE CONTROL MATERIALS 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.:

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