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FDA-Registered Company Profile for ROCHE DIAGNOSTICS GMBH
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 (Map)
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
Other Establishment Information:
Establishment Phone:
Fax:
General Email:
Web Site: http://www.roche-diagnostics.com
Company Brochure:
Keywords:
Company Description:
Services Offered:
About Us:
Differentiation:


FDA-Registered Products Offered by ROCHE DIAGNOSTICS GMBH
Common Device Name Proprietary Device Name
1 ACID PHOSPHATASE MULTIPLE PRODUCT NAMES
2 ACID PHOSPHATASE ACID PHOSPHATASE
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 SYSTEM, TEST, BETA-2-MICROGLOBULIN IMMUNOLOGICAL PRODUCTS TINA-QUANT BETA 2 MICROGLOBULIN
71 VARIOUS COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE PRODUCTS MULTIPLE PRODUCT NAMES
72 VARIOUS ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C PRODUCTS MULTIPLE PRODUCT NAMES
73 VARIOUS CALIBRATOR, PRIMARY PRODUCTS MULTIPLE PRODUCT NAMES
74 VARIOUS ENZYME IMMUNOASSAY, METHADONE PRODUCTS MULTIPLE PRODUCT NAMES
All FDA-Registered products for this company are displayed above.


Other Products Offered by ROCHE DIAGNOSTICS GMBH:
 No products have been listed by this company.

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


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


Companies Related to ROCHE DIAGNOSTICS GMBH

 Our records indicate that the following companies are related by ownership.
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  Company Name Address City State Zip Country
1 ROCHE DIAGNOSTICS GMBH FRIEDRICH-EBERT-STRABE 100 MANNHEIM 68167 GM
2 ROCHE DIAGNOSTICS LTD. FORRENSTRASSE ROTKREUZ CH-6343 SZ


Competitors of ROCHE DIAGNOSTICS GMBH

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