The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Norovirus, Genexpert Dx Systems (gx-i, Gx-11, Gx-iv, Gx-xvi), Genexpert Infinity-48 System, Genexpert Infinity-48s System, Genexpert Infinity-80 System.
| Device ID | K142501 |
| 510k Number | K142501 |
| Device Name: | Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Kerry J. Flom |
| Correspondent | Scott A. Campbell CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Product Code | PCH |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-05 |
| Decision Date | 2014-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940000974 | K142501 | 000 |