[ Edit this Company] 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, CANNABINOIDS PRODUCTS MULTIPLE PRODUCT NAMES 48 VARIOUS DRUG MIXTURE CONTROL MATERIALS PRODUCTS MULTIPLE PRODUCT NAMES 49 VARIOUS ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES PRODUCTS MULTIPLE PRODUCT NAMES 50 VARIOUS FLUOROMETRY, MORPHINE PRODUCTS MULTIPLE PRODUCT NAMES 51 VARIOUS ENZYME IMMUNOASSAY, PHENCYCLIDINE PRODUCTS ONTRAK TEST CUPS 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. [ About ] [ Contact ] [ Login ] © 2025 Medevnet.com - All Rights Reserved