Definition: A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of MRSA Colonization Status For The Prevention And Control Of MRSA Infections In Healthcare Settings.
| Device Type ID | 3515 |
| Device Name | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.1640 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NQX |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3515 |
| Device | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Product Code | NQX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| CFR Regulation Number | 866.1640 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CEPHEID | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
No Apparent Adverse Event | 2 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Becton Dickinson & Co. | II | Sep-10-2014 |
| 2 | Cepheid | II | Aug-16-2016 |
| 3 | Roche Molecular Systems, Inc. | II | Mar-26-2018 |