Roche Molecular Systems, Inc.

Lots T10786 T13091, T15435, T15475, T14777, and W00389

Immunology and Microbiology Devices

3

No

Foreign Distributed.

cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. || Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.

T08661

Immunology and Microbiology Devices

3

No

Foreign

cobas¿ EGFR Mutation Test || epidermal growth factor receptor (EGFR) gene DNA assay

5666678001

Hematology and Pathology Devices

Unclassified

No

Nationwide (USA) Distribution

Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.

Material Number 05200881001 - all lot/serial numbers.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

cobas¿ 4800 system z480 instrument. || Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

05852170190; Lot P06778

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - including the countries of Austria, Belgium, Czech Republic, Denmark, Germany, Italy, Luxemburg, Netherlands, Poland, Slovakia, Slovenia, Spain, United Kingdom, Canada, Chile, Greenland, Hong Kong, Israel, Malaysia, New Zealand, Philippines, S. Africa, Switzerland, Taiwan and Turkey.

Cobas KRAS Mutation Test for In Vitro Diagnostic Use || Product Usage: Usage: || The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC).