Test, Factor V Leiden Mutations, Genomic Dna Pcr
Device Code: 4900
Product Code(s):
NPQ Definition: In Vitro Diagnostic Test To Detect The Factor V Leiden Mutation In Genomic DNA, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia.
Device Classification Information
| Device Type ID | 4900 |
| Device Name | Test, Factor V Leiden 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 | NPQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 4900 |
| Device | Test, Factor V Leiden Mutations, Genomic Dna Pcr |
| Product Code | NPQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Factor V Leiden DNA Mutation Detection Systems. |
| CFR Regulation Number | 864.7280 [🔎] |
TPLC Last Update: 2019-04-02 20:57:14