The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Mrsa/sa Blood Culture, Genexpert Dx System, Genexpert Infinity-48s System, Genexpert Infinity-80 System.
| Device ID | K190771 |
| 510k Number | K190771 |
| Device Name: | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Contact | Yi-ping Lin |
| Correspondent | Sudhakar Marla Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Product Code | NQX |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-26 |
| Decision Date | 2019-04-25 |