Definition: In Vitro Diagnostic Test To Detect The Factor II G20210A Mutation In Genomic DNA, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia.
| Device Type ID | 4901 |
| Device Name | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr |
| Regulation Description | Factor V Leiden DNA Mutation Detection Systems. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.7280 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NPR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4901 |
| Device | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr |
| Product Code | NPR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Factor V Leiden DNA Mutation Detection Systems. |
| CFR Regulation Number | 864.7280 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |