Identifiers
- 510(k) Number
- K223046 FDA 510(k)
- FDA Product Code
- NPR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7280 FDA 510(k)
- Regulation Number
- 864.7280 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Xpert FII & FV is a device used for genomic dna pcr testing, specifically for Factor Ii G20210a Mutations. It is classified as a device in the Hematology medical specialty. The device is substantially equivalent and has a special clearance type. It is used for testing genomic dna.
The Xpert FII & FV is supplied with a product code of NPR and a regulation number of 864.7280. It has been authorized with an FDA 510K clearance. The device is associated with the manufacturer Cepheid and has a device class of 2. It is registered with fei numbers 3016838963, 3004530258, 2243471, and 3005406097.
Frequently asked questions
What is the Xpert FII & FV device used for?
The Xpert FII & FV is used for genomic DNA PCR testing, specifically for detecting Factor II G20210A mutations, which is a type of genetic test in the field of Hematology.
What is the regulatory status of the Xpert FII & FV device?
The Xpert FII & FV has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a predicate device.
How is the Xpert FII & FV device classified?
The Xpert FII & FV is classified as a Class 2 device in the Hematology medical specialty, with a product code of NPR and a regulation number of 864.7280.
What are the associated FEI numbers for the Xpert FII & FV device?
The Xpert FII & FV device is registered with FEI numbers 3016838963, 3004530258, 2243471, and 3005406097.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223046 | Class II | Active |
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Manufacturer
- Manufacturer
- Cepheid®
Sources (1)
- FDA 510(k) K223046 24 fields · synced Sep 25, 2026