Change to remove extraneous in-process stability tests performed on the strips (str) and on the solid phase receptacles (spr) of the kit, and consequently to add an instruction for the storage of the str during the manufacturing process.
| Device | VIDAS TOTAL PSA |
| Generic Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Applicant | BioMerieux, Inc. |
| Date Received | 2015-03-18 |
| Decision Date | 2015-04-22 |
| PMA | P040008 |
| Supplement | S011 |
| Product Code | MTF |
| Advisory Committee | Immunology |
| Supplement Type | 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 |
|---|
| P040008 | | Original Filing |
| S013 |
2016-05-03 |
30-day Notice |
| S012 |
2015-07-06 |
30-day Notice |
| S011 |
2015-03-18 |
30-day Notice |
| S010 | | |
| S009 | | |
| S008 |
2014-02-03 |
30-day Notice |
| S007 |
2013-08-15 |
30-day Notice |
| S006 |
2013-02-12 |
30-day Notice |
| S005 |
2013-02-06 |
30-day Notice |
| S004 |
2012-12-18 |
30-day Notice |
| S003 |
2012-10-11 |
Real-time Process |
| S002 |
2012-01-09 |
30-day Notice |
| S001 |
2008-09-04 |
30-day Notice |
NIH GUDID Devices