ROCHE DIAGNOSTICS LTD.

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FDA-Registered Company Profile for ROCHE DIAGNOSTICS LTD.

FDA-Supplied Establishment Information:

Establishment Registration Number:

3003795116

Company Name:

ROCHE DIAGNOSTICS LTD.

Also Known As:

ROCHE MOLECULAR SYSTEMS, INC.

Address:

FORRENSTRASSE

Address 2:

City:

ROTKREUZ

State

Zip / Postal Code:

CH-6343

County:

Country:

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:

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:

Zip / Postal Code:

46250 0457

Country:

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:

Zip Code:

46250

Country:

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 LTD.
	Common Device Name	Proprietary Device Name
1	CLINICAL ANALYZER	COBAS CORE II, ELECSYS 1010 ANALYZER, COBAS INTEGRA 400 PLUS,COBAS INTEGRA 800
2	PRIMARY SAMPLE DISTRIBUTOR	PSD-1
All FDA-Registered products for this company are displayed above.

Other Products Offered by ROCHE DIAGNOSTICS LTD.:

No products have been listed by this company.

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

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

FDA-Registered Company Profile for ROCHE DIAGNOSTICS LTD.

FDA-Registered Products Offered by ROCHE DIAGNOSTICS LTD.

Other Products Offered by ROCHE DIAGNOSTICS LTD.:

Services Offered by the ROCHE DIAGNOSTICS LTD.:

Additional Contact Information for ROCHE DIAGNOSTICS LTD.:

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