Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
Device Code: 3612
Product Code(s):
NWY Definition: Intended For The Detection Of IgM And IgG Antibodies To Dengue Virus In Human Serum, Plasma Or Whole Blood.
Device Classification Information
| Device Type ID | 3612 |
| Device Name | Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies |
| Physical State | In-vitro Diagnositc Test |
| Technical Method | In-vitro Diagnostic Test |
| Target Area | In-vitro Diagnostic Test |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | NWY |
| 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 | 3612 |
| Device | Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies |
| Product Code | NWY |
TPLC Last Update: 2019-04-02 20:33:12