← Back to catalogue
Xpert Mrsa/Sa Blood Culture Assay +3 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K130894
by Cepheid
Identifiers
- 510(k) Number
- K130894 FDA 510(k)
- FDA Product Code
- NQX FDA 510(k)
- Models / Variants
- Xpert Mrsa/Sa Blood Culture Assay FDA 510(k)Genexpert Infinity-48 System FDA 510(k)Gene 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)
Xpert Mrsa/Sa Blood Culture Assay +3 more models by Cepheid — Class II — FDA_510K — listed in FDA 510(k) — 4 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130894 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cepheid
Sources (1)
- FDA 510(k) K130894 24 fields · synced Jun 18, 2026