The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Mrsa/sa Blood Culture Assay; Genexpert Dx Systems (gx-i, Gx-ii, Gx-iv, Gx-xvi); Genexpert Infinity-48 System; Gene.
| Device ID | K130894 |
| 510k Number | K130894 |
| Device Name: | XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Rainer Ziermann Ph.d. |
| Correspondent | Rainer Ziermann Ph.d. CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Product Code | NQX |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-01 |
| Decision Date | 2013-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940000141 | K130894 | 000 |