The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas B.r.a.h.m.s. Pct Assay.
| Device ID | K071146 |
| 510k Number | K071146 |
| Device Name: | VIDAS B.R.A.H.M.S. PCT ASSAY |
| Classification | Antigen, Inflammatory Response Marker, Sepsis |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Nikita S Mapp |
| Correspondent | Nikita S Mapp BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | NTM |
| CFR Regulation Number | 866.3210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-24 |
| Decision Date | 2007-10-11 |
| Summary: | summary |