Roche Molecular Systems, Inc.

Version 3.1.0, Version 3.1.1, Version 3.1.2, Version 3.2.0, Version 3.2.1, and Version 3.2.2.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution

AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. || Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.

Catalog number 03576710190, working substrate SB3-SB

Immunology and Microbiology Devices

3

No

Nationwide to hospitals and laboratories.

Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 || COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0

Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122, Working substrate SB3-SB

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide to hospitals and laboratories.

Amplilink Software versions 1.1, 1.3, 1.4, 2.41. || COBAS Amplicor CTA & NGA Tests

European Distribution: Model number 4381866190 (CE-IVD) Batches: H08500, H13591, H14242, J00383, J00814

Clinical Chemistry and Clinical Toxicology Devices

2

No

World wide Distribution --- USA including states of MI, IN, NC, CA KY, IN, VA, and FL.and countries of Netherlands, Germany, Sweden, Denmark, Italy, Spain, Belgium, Switzerland, and Hungary

AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.

US Distribution: Model Number: 4591402190 (US-IVD) Batches: H08499, H10626, H13592, J00807, J00815.

Clinical Chemistry and Clinical Toxicology Devices

2

No

World wide Distribution --- USA including states of MI, IN, NC, CA KY, IN, VA, and FL.and countries of Netherlands, Germany, Sweden, Denmark, Italy, Spain, Belgium, Switzerland, and Hungary

AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics