Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System…
FDA 510(k)Class II (US FDA 510(k))
by Cepheid
Identifiers
- 510(k) Number
- K190771 FDA 510(k)
- FDA Product Code
- NQX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1640 FDA 510(k)
- Regulation Number
- 866.1640 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Xpert MRSA/SA Blood Culture is a Nucleic Acid Amplification Test (NAAT) for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from positive blood culture specimens. It employs automated real-time PCR to amplify and identify target genetic sequences, enabling rapid identification of bacterial presence and resistance markers in clinical microbiology settings.
This system is supplied as a qualitative in vitro diagnostic test for use on the GeneXpert Dx, Infinity-48s, or Infinity-80 platforms, each configured for automated processing. The test is intended for single-use, with no sterility claims specified; compatibility with MRI environments is not addressed in the data. Authorisations include an FDA 510(k) clearance under Special Review (K190771), classified as a Class II device (NQX product code). Storage and handling conditions are not detailed in the provided specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity ..., Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity ..., PDF Xpert MRSA/SA Blood Culture - infomine.cepheid.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190771 | Class II | Active |
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Manufacturer
- Manufacturer
- Cepheid
Sources (1)
- FDA 510(k) K190771 24 fields · synced Oct 6, 2026