ROCHE MOLECULAR SYSTEMS, INC.

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FDA-Registered Company Profile for ROCHE MOLECULAR SYSTEMS, INC.

FDA-Supplied Establishment Information:

Establishment Registration Number:

3004141078

Company Name:

ROCHE MOLECULAR SYSTEMS, INC.

Address:

4300 HACIENDA DRIVE

Address 2:

City:

PLEASANTON

State

Zip / Postal Code:

94588-2722

County:

ALAMEDA

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:

2243471

Company Name:

ROCHE MOLECULAR SYSTEMS, INC.

Address:

4300 HACIENDA DRIVE

Address 2:

City:

PLEASANTON

State:

Zip / Postal Code:

94588

Country:

Owner/Operator Phone:

925-730-8110

FDA-Supplied Official Correspondent Information:

Official Correspondent Name:

MS. KAREN LONG

Company Name:

ROCHE MOLECULAR SYSTEMS, INC.

Address:

4300 HACIENDA DRIVE

Address 2:

City:

PLEASANTON

State:

Zip / Postal Code:

94588 2722

Country:

Official Corespondent Phone Number:

925-730-8110

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 MOLECULAR SYSTEMS, INC.
	Common Device Name	Proprietary Device Name
1	BLOOD POOLING/DATA OUTPUT MANAGEMENT SYSTEM SOFTWARE	ROCHE COBAS AMPLISCREEN DATA OUTPUT MANAGEMENT SYSTEM (DOMS)
2	CYTOCHROME P450 CYP2C19 TEST, CYTOCHROME P450 CYP2D6 TEST	ROCHE AMPLICHIP CYP450 TEST
3	MYCOBACTERIUM TUBURCULOSIS TEST	AMPLICOR(R) MYCOBACTERIUM TUBURCULOSIS TEST
4	NUCLEIC ACID CHEMISTRY ANALYZER	MULTIPLE (ROCHE COBAS AMPLICOR ANALYZER, ROCHE COBAS TAQMAN ANALYZER)
5	SAMPLE PREPARATION FOR NUCLEIC ACID TESTING	ROCHE COBAS AMPLIPREP INSTRUMENT
6	VARIOUS CHLAMYDIA THRACHOMATIS TESTS, CHLAMYDIA SEROLOGICAL REAGENTS	AMPLICOR(R) CT/NG TEST,COBAS AMPLICOR(TM) CT/NG TEST.COBAS AMPLICOR CT TEST
7	VARIOUS HEPATITIS C VIRUS TESTS	AMPLICOR(R) HCV TEST, V2.0, COBAS AMPLICOR(TM) HCV TEST, V2.0
8	VARIOUS HIV-1 MONITOR TESTS	AMPLICOR HIV-1 MONITOR(R) TEST AND COBAS AMPLICOR HIV-1 MONITOR(TM) TEST
9	VARIOUS NEISSERIA GONORRHOEA TESTS, GONORRHOEA SEROLOGICAL REAGENTS	AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEA,COBAS AMPLICOR CT/NG TEST FOR NG
10	VARIOUS TYPES OF ANALYTES	MULTIPLE PRODUCT NAMES
All FDA-Registered products for this company are displayed above.

Other Products Offered by ROCHE MOLECULAR SYSTEMS, INC.:

No products have been listed by this company.

Services Offered by the ROCHE MOLECULAR SYSTEMS, INC.:
No services have been listed by this company.

Additional Contact Information for ROCHE MOLECULAR SYSTEMS, INC.:
There is no additional contact information for this company.

FDA-Registered Company Profile for ROCHE MOLECULAR SYSTEMS, INC.

FDA-Registered Products Offered by ROCHE MOLECULAR SYSTEMS, INC.

Other Products Offered by ROCHE MOLECULAR SYSTEMS, INC.:

Services Offered by the ROCHE MOLECULAR SYSTEMS, INC.:

Additional Contact Information for ROCHE MOLECULAR SYSTEMS, INC.:

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