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FDA-Registered Company Profile for ROCHE DIAGNOSTICS GMBH
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| FDA-Supplied Establishment Information: |
|
| Establishment Registration Number: |
9610126 |
| Company Name: |
ROCHE DIAGNOSTICS GMBH |
| Also Known As: |
BOEHRINGER MANNHEIM CORP.
ROCHE MOLECULAR BIOCHEMICALS
|
| Address: |
SANDHOFER STRASSE 116 |
| Address 2: |
|
| City: |
MANNHEIM |
| State |
|
| Zip / Postal Code: |
D-68298 |
| County: |
|
| Country: |
GM |
| Establishment Operation Code(s): |
MM - Manufacturer
MS - Specification Developer
|
| Establishment Status Code: |
A -
Active
|
Year of Most Recent Initial
or Annual Registration: |
2007 |
| FDA-Supplied Owner/Operator Information: |
| Owner/Operator Number: |
9039767 |
| Company Name: |
CORANGE DEUTSCHLAND HOLDING GMBH
|
| Address: |
SANDHOFER STRASSE 116 |
| Address 2: |
|
| City: |
MANNHEIM |
| State: |
|
| Zip / Postal Code: |
D-68305 |
| Country: |
GM |
| Owner/Operator Phone: |
49-621-7670
|
| FDA-Supplied Official Correspondent Information: |
| Official Correspondent Name: |
DR. ERIC KOLODZIEJ |
| Company Name: |
ROCHE DIAGNOSTICS CORP. |
| Address: |
9115 HAGUE RD |
| Address 2: |
|
| City: |
INDIANAPOLIS |
| State: |
IN |
| Zip / Postal Code: |
46250 0457 |
| Country: |
US |
| Official Corespondent Phone Number: |
317-521-2834
|
| FDA-Supplied US Agent Information: |
| US Agent Contact Name / Title: |
DR. ERIC KOLODZIEJ , VP REGULATORY COMPLIANCE & QUALITY |
| Company Name: |
ROCHE DIAGNOSTICS CORP. |
| Address: |
9115 HAGUE RD. |
| Address 2: |
|
| City: |
INDIANAPOLIS |
| State: |
IN |
| Zip Code: |
46250 |
| Country: |
US |
| US Agent Phone Number: |
317-521-2834 |
| US Agent Email Address: |
eric.kolodziej@roche.com
|
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|
| Other Establishment Information: |
| Establishment Phone: |
|
| Fax: |
|
| General Email: |
|
| Web Site: |
http://www.roche-diagnostics.com
|
| Company Brochure: |
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| Keywords: |
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| Company Description: |
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| Services Offered: |
|
| About Us: |
|
| Differentiation: |
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FDA-Registered Products Offered by ROCHE DIAGNOSTICS GMBH
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|
Common Device Name |
Proprietary Device Name |
| 1 |
ACID PHOSPHATASE |
ACID PHOSPHATASE |
| 2 |
ACID PHOSPHATASE |
MULTIPLE PRODUCT NAMES |
| 3 |
ALBUMIN, FITC, ANTIGEN, ANTISERUM, CONTROL |
ALBUMIN, FITC, ANTIGEN, ANTISERUM, CONTROL |
| 4 |
ALCOHOL |
ALCOHOL U.V. |
| 5 |
ALDOLASE |
ALDOLASE |
| 6 |
ALKALINE PHOSPHATASE |
MULITPLE |
| 7 |
ALPHA-FETOPROTEIN ASSAY |
ELECSYS AFP ASSAY |
| 8 |
AMMONIA |
AMMONIA (U.V.) |
| 9 |
AMYLASE |
AMYLASE |
| 10 |
ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT |
TINA-QUANT ASLO |
| 11 |
ASSAY FOR DETERMINATION OF VITAMIN B12 |
RADIOASSAY, VITAMIN B12 |
| 12 |
AUTOMATED URINE TEST STRIP SCANNER |
UROTRON |
| 13 |
BILIRUBIN |
MULTIPLE PRODUCT NAMES |
| 14 |
BLOOD LANCET |
ACCU-CHEK MULTICLIX; ACCU-CHEK SOFTCLIX; ACCU-CHEK SAFE-T-PRO; COAGUCHEK SOFTCLI |
| 15 |
CALIBRATORS FOR MULTIPLE ANALYTES |
CALIBRATOR, MULTI-ANALYTE MIXTURE |
| 16 |
CLINICAL USE REFLECTANCE TLC/DENSITOMETER/SCANNER |
NO PROPRIETARY NAME LISTED |
| 17 |
CONTROL FOR COBAS INTEGR C-REACTIVE PROTEIN ASSAY |
COBAS INTEGRA C-REACTIVE PROTEIN CONTROL |
| 18 |
CREATINE KINASE TEST |
U.V. SYSTEM CK-NAC |
| 19 |
CREATININE |
CREATININE ENZYMATIC |
| 20 |
CYSTEINE |
CYSTEINE |
| 21 |
D-DIMER TEST SYSTEM |
TINA-QUANT D-DIMER |
| 22 |
DIABETES MANAGEMENT SOFTWARE |
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE |
| 23 |
DILUENT FOR ESTRADIOL/PROGESTERONE |
ELECSYS DILUENT ESTRADIOL/PROGESTERONE |
| 24 |
ELECTRO ASSAY |
ELECSYS IGE |
| 25 |
ELECTRO CHEMILUMNESCENCE ASSAY FOR DETERMINATION OF PROGESTERONE |
ELECSYS PROGESTERONE |
| 26 |
ELECTROCHEM. ASSAY |
ELECSYS MYOGLOBIN |
| 27 |
ELECTROCHEMILUMINESCENCE ASSAY |
ELECRYS DIGOXN |
| 28 |
ELECTROCHEMILUMINESCENCE ASSAY FOR DETERMINATION OF HUMAN LUTEINIZING HORMONE |
ELECSYS LH ASSAY |
| 29 |
ELECTROCHEMILUMINESCENCE ASSAY FOR THE DETERMINATION OF CARCINOEMLORYONIC |
ELECSYS CEA ASSAY |
| 30 |
ELECTROCHEMILUMINISCENCE ASSAY FOR DETERMINATION OF HUMAN FOLLICLE STIMULATING H |
ELECSYS FSH ASSAY |
| 31 |
ELECTROCHEMILUNUNESCENCE ASSAY FOR DETERMINATION OF CA 15-3 |
ELECSYS CA 15-3 ASSAY |
| 32 |
ELECTROCHENUCLUMINESCENCE ASSAY FOR DETERMINATION OF THYROBULIN |
ELECSYS THYROGLOBULIN IMMINOASSAY |
| 33 |
ELECTROCHENULUNINESCENCE ASSAY FOR DETERMINATION OF HEPATITIS BS AG |
ELECSYS H BS AG IMNUNOASSAY |
| 34 |
ENZYMUN TEST FERRITIN (ENZYME IMMUNE ASSAY) |
ENZYMUN TEST FERRITIN |
| 35 |
ENZYMUN TEST T3 |
ENZYMUN TEST T3 |
| 36 |
ENZYMUN TEST T4 (ENZYME IMMUNE ASSAY) |
ENZYMUN TEST T4 |
| 37 |
ENZYMUN TEST TBG (ENZYME IMMUNE ASSAY) |
ENZYMUN TEST TBG |
| 38 |
ENZYMUN TEST TSH AND TSH-S (ENZYME IMMUNE ASSAY) |
ENZYMUN TEST TSH AND TSH-S |
| 39 |
EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN |
ELECSYS CA 125 II |
| 40 |
FETAL HEMOGLOBIN |
FETAL HEMOGLOBIN |
| 41 |
GAMMA-GT |
MULTIPLE PRODUCT NAMES |
| 42 |
GLUCOSE-6-PHOSPHATE DEHYDROGENASE |
G-6-PDH |
| 43 |
HBDH |
MULTIPLE PRODUCT NAMES |
| 44 |
HCG (ENZYME) |
B-HCG |
| 45 |
HDL CHOLESTEROL |
HDL CHOLESTEROL |
| 46 |
IMMUNOASSAY METHOD, TROPONIN SUBUNIT |
IMMUNOASSAY METHOD, TROPONIN SUBUNIT |
| 47 |
IMMUNOTURBIDIMETRIC ASSAY FOR THE DETERMINATION OF 2-1 ANTITRYPSIN |
TINA-QUANT 2-1-ANTITRYPSIN ASSAY |
| 48 |
IMMUNOTURBIDOMETRIC ASSAY FOR HE DETERMINATION OF HAPTOGLOBIN |
TINA-QUANT HAPTOGLOBIN ASSAY |
| 49 |
IMMUNOTURBIDOMETRIC ASSAY FOR THE DETERMINATION OF PREALBUMIN |
TINA-QUANT PREALBUMIN ASSAY |
| 50 |
IMMUNOTURBIDOMETRIC ASSAY FOR THE DETERMINATION OF RHEUMATOID FACTOR |
TINA-QUANT RHEUMATOID FACTOR ASSAY |
| 51 |
LAP |
LAP |
| 52 |
LIGHT CYCLER CENTRIFUGE, ROTOR, AND ADAPTORS;SOFTWARE3;SAMPLE CAROUSEL MAGNAPURE |
LIGHT CYCLER ACCESSORIES, MAGNAPURE ACCESSORIES |
| 53 |
LINEAR ARRAY PANEL FOR DETECTION OF CF MUTATIONS |
LINEAR ARRAY CF GOLD 1.0 |
| 54 |
MAGNESIUM |
MAGNESIUM |
| 55 |
MONITORING OF COBAS INTEGRA CYCLOSPORINE |
COBAS INTEGRA CYCLOSPORINE |
| 56 |
MULTIANALYTE CONTROLS |
MULTIPLE PRODUCT NAMES |
| 57 |
MULTIENZYME CONTROLS |
MULTIPLE PRODUCT NAMES |
| 58 |
NO COMMON NAME LISTED |
NO PROPRIETARY NAME LISTED |
| 59 |
POTASSIUM REAGENT KIT-POTASSIUM STANDARD KIT |
FLAME PHOTOMETRY, POTASSIUM |
| 60 |
RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) |
ELECSYS DHEA S ASSAY |
| 61 |
RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN |
RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN |
| 62 |
SAME |
NO PROPRIETARY NAME LISTED |
| 63 |
SAME |
NO PROPRIETARY NAME LISTED |
| 64 |
SAME |
NO PROPRIETARY NAME LISTED |
| 65 |
TINA-QUANT A C3 FOR HITACHI |
TINA-QUANT A C3 |
| 66 |
TINA-QUANT A C4 FOR HITACHI |
TINA-QUANT A C4 |
| 67 |
TINA-QUANT A CRP FOR HITACHI |
TINA-QUANT A CRP |
| 68 |
TINA-QUANT A IGM FOR HITACHI |
TINA-QUANT A IGM |
| 69 |
TINA-QUANT A TRANSFERRIN FOR HITACHI |
TINA-QUANT A TRANSFERRIN |
| 70 |
VARIOUS ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 71 |
VARIOUS CALIBRATOR, PRIMARY PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 72 |
VARIOUS ENZYME IMMUNOASSAY, METHADONE PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 73 |
VARIOUS SYSTEM, TEST, BETA-2-MICROGLOBULIN IMMUNOLOGICAL PRODUCTS |
TINA-QUANT BETA 2 MICROGLOBULIN |
| 74 |
VARIOUS COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE PRODUCTS |
MULTIPLE PRODUCT NAMES |
| All FDA-Registered products for this company are displayed above. |
