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FDA-Registered Company Profile for ROCHE DIAGNOSTICS GMBH

FDA-Supplied Establishment Information:
Establishment Registration Number: 9610529
Company Name: ROCHE DIAGNOSTICS GMBH
Address: NONNENWALD 2
Address 2:
City: PENZBERG
State
Zip / Postal Code: D-82377
County:
Country: GM
Establishment Operation Code(s): MM - Manufacturer
Establishment Status Code: A - Active
Year of Most Recent Initial
or Annual Registration:
2007
FDA-Supplied Owner/Operator Information:
Owner/Operator Number: 9036646
Company Name: ROCHE DIAGNOSTICS GMBH MANNHEIM
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
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 ROAD
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:
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 ACTH TEST SYSTEM ELECSYS ACTH TEST SYSTEM
2 ALPHA-FETOPROTEIN TEST ELECSYS AFP
3 ANTI-THYROID PEROXIDASE ANTIBODY TEST ELECSYS ANTI-TPO ASSAY
4 BETA-CROSSLAPS IMMUNOASSAY ELECSYS BETA-CROSSLAPS SERUM IMMUNOASSAY
5 C-REACTIVE PROTEIN, HIGH SENSITIVITY TINA-QUANT CRP (LATEX) HIGH SENSITIVITY
6 CA 15-3 IMMUNOASSAY ELECSYS CA 15-3 TEST SYSTEM
7 CA125 IMMUNOASSAY ELECSYS CA125 ASSAY
8 CALIBRATOR C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
9 CARCINOEMBRYONIC ANTIGEN IMMUNOASSAY ELECSYS CEA ASSAY
10 CK-MB ASSAY ELECSYS CK-MB STAT
11 COAGULATION CONTROLS COAGUCHEK XS PT CONTROLS
12 CORTISOL TEST SYSTEM ELECSYS CORTISOL
13 CORTISOL TEST SYSTEM ELECSYS CORTISOL TEST SYSTEM
14 DATA PROCESSOR OMNILINK 3.4
15 DHEA-S ASSAY ELECSYS DHEA-S ASSAY
16 DIGOXIN IMMUNOASSAY ELECSYS DIGOXIN ASSAY
17 ELECSYS 1010, ELECSYS 2010 ELECSYS ANALYZER 1010, ELECSYS ANALYZER 2010
18 ESTRADIOL IMMUNOASSAY ELECSYS ESTRADIOL ASSAY
19 FACTOR II MUTATION ASSAY FACTOR II (PROTHROMBIN) G20210A KIT
20 FERRITIN ASSAY ELECSYS FERRITIN ASSAY
21 FOLIC ACID ASSAY ELECSYS FOLATE ASSAY, ELECSYS RBC FOLATE REAGENT
22 FOLLICLE-STIMULATING HORMONE ASSAY ELECSYS FSH ASSAY
23 FREE T4 ASSAY ELECSYS FT4 ASSAY
24 HCG TEST SYSTEM ELECSYS HCG TEST SYSTEM
25 HEPATITIS B SURFACE ANTIGEN ASSAY ELECSYS HBSAG ASSAY
26 IMMUNOASSAY CALIBRATORS ELECSYS CALSET PRODUCTS
27 IMMUNOASSAY CALIBRATORS ELECSYS TESTOSTERONE CALSET, ELECSYS FSH CALSET, ELESYS ESTRADIOL ELECSYS CEA CA
28 IMMUNOASSAY CONTROLS ELECSYS CALCHECK PRODUCTS
29 IMMUNOASSAY CONTROLS ELECSYS CALCHECK TROPONIN, CALCHECK MYOGLOBIN, CALCHECK FOLATE, CAL CHECK IGE
30 IMMUNOASSAY-BONE MARKER COBAS ELECSYS N-MID OSTEOCALCIN
31 IMMUNOASSAY-CANCER MARKER ELECSYS CA 19-9
32 IMMUNOGLOBULIN E ASSAY ELECSYS IGE ASSAY
33 IMMUNOGLOBULIN TEST TINA-QUANT IGG GEN2
34 INSULIN IMMUNOASSAY ELECSYS INSULIN ASSAY
35 LUTEINIZING HORMONE ASSAY ELECSYS LH ASSAY
36 MYCOPHENOLIC ACID ASSAY ROCHE TOTAL MYCOPHENOLIC ACID ASSAY
37 MYOGLOBIN ASSAY ELECSYS MYOGLOBIN STAT ASSAY
38 PIPETTING AND DILUTING SYSTEM FOR CLINICAL VS II ALIQUOTER
39 PROGESTERONE ASSAY ELECSYS PROGESTERONE ASSAY
40 PROLACTIN ASSAY ELECSYS PROLACTIN ASSAY
41 PSA ASSAY ELECSYS PSA ASSAY
42 PTH ASSAY ELECSYS PARATHYROID HORMONE TEST SYSTEM
43 T-UPTAKE ASSAY ELECSYS T-UPTAKE ASSAY
44 T4 ASSAY ELECSYS T4 ASSAY
45 TESTOSTERONE ASSAY ELECSYS TESTOSTERONE ASSAY
46 THYROGLOBULIN ASSAY ELECSYS TG ASSAY
47 TRIIODOTHYRONINE ASSAY ELECSYS FT3 ASSAY, ELECSYS T3 ASSAY
48 TROPONIN IMMUNOASSAY ELECSYS TROPONIN T ASSAY
49 TSH ASSAY ELECSYS TSH ASSAY
50 VITAMIN B12 ASSAY ELECSYS VITAMIN B12 ASSAY
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.






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