|Trade Name||COBAS 4800 BRAF V600 MUTATION TEST|
|Classification Name||somatic gene mutation detection system|
|Applicant||ROCHE MOLECULAR SYSTEMS, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes to the filling and labeling equipment and location for certain vialed intermediate components. Your firm has proposed relocation to building 502 rooms 1f24 and 1f26 from building 502 rooms 1f23 and 1f31 for use of new equipment kugler linoline 120 filing and screw-capping line which includes the accraply 4000 and 35t labeling machines.