Definition: Qualitative Detection Of Dengue Virus Antigen In Human Serum Or Plasma Collected From Human Patients With Signs And Symptoms Consistent With Dengue Virus Infection
| Device Type ID | 3592 |
| Device Name | Dengue Virus Antigen Assay |
| Physical State | ELISA Kit Including Different Components, I.e., ELISA Plates Coated With Antibodies, Other Capture Antibodies, Positive And Negative Controls Etc. |
| Technical Method | Immunoassay E.g., ELISA |
| Target Area | Human Serum Or Plasma Or Whole Blood Or Body Fluid Collected From Patient |
| Regulation Description | Dengue Virus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3945 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QCU |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3592 |
| Device | Dengue Virus Antigen Assay |
| Product Code | QCU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Dengue Virus Serological Reagents. |
| CFR Regulation Number | 866.3945 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INBIOS INT'L INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |