The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Mrsa/sa Nasal Assay.
| Device ID | K100822 |
| 510k Number | K100822 |
| Device Name: | XPERT MRSA/SA NASAL ASSAY |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Russel K Enns |
| Correspondent | Russel K Enns 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 | 2010-03-23 |
| Decision Date | 2010-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940000165 | K100822 | 000 |
| 07332940000158 | K100822 | 000 |