Approval for the following seven changes: cleaning of dripping and spheres filling equipment, transfer of quality control activities into another room, raw material changes for bottles and caps for thxid-braf pur, modification of a functional quality control (qc) test for the thxidtm-braf pur kit, transfer of buffer manufacturing (for the braf purification kit) into a new building at qiagen, changes in dnase reference (am2224) used in the determination of dnase activity in water and reagents, and shelf life extension for rna transcripts and plasmids.
| Device | THXID BRAF KIT |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | BioMerieux, Inc. |
| Date Received | 2014-10-15 |
| Decision Date | 2014-12-22 |
| PMA | P120014 |
| Supplement | S002 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | bioMerieux, Inc. 595 Anglum Rd. hazelwood, MO 63042 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P120014 | | Original Filing |
| S012 |
2021-11-23 |
30-day Notice |
| S011 |
2021-02-12 |
30-day Notice |
| S010 |
2020-01-31 |
30-day Notice |
| S009 |
2019-08-07 |
30-day Notice |
| S008 |
2017-07-03 |
Normal 180 Day Track |
| S007 |
2016-10-27 |
30-day Notice |
| S006 |
2016-01-11 |
Normal 180 Day Track |
| S005 |
2015-05-08 |
30-day Notice |
| S004 |
2015-03-03 |
Special (immediate Track) |
| S003 |
2015-02-24 |
Normal 180 Day Track |
| S002 |
2014-10-15 |
135 Review Track For 30-day Notice |
| S001 |
2014-10-10 |
135 Review Track For 30-day Notice |
NIH GUDID Devices