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Xpert Gbs Lb Genexpert Dx Systems (gx-I, Gx-Iv) Genexpert Dx Systems (gx-Xvi) G…
FDA 510(k)Class I (US FDA 510(k))
510(k) K121539
by Cepheid
Identifiers
- 510(k) Number
- K121539 FDA 510(k)
- FDA Product Code
- NJR FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3740 FDA 510(k)
- Regulation Number
- 866.3740 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Xpert Gbs Lb Genexpert Dx Systems (gx-I, Gx-Iv) Genexpert Dx Systems (gx-Xvi) G… by Cepheid — Class I — FDA_510K — listed in FDA 510(k)
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 | K121539 | Class I | Active |
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Manufacturer
- Manufacturer
- Cepheid
Sources (1)
- FDA 510(k) K121539 24 fields · synced Jun 18, 2026