Dengue Serological Reagents
Device Code: 3537
Product Code(s):
OSU Definition: Dengue Virus Serological Reagents Are Devices That Consist Of Antigens And Antisera For The Detection Of Anti-dengue Antibodies, Individuals That Have Signs And Symptoms Consistent With Dengue. The Detection Aids In The Clinical Laboratory Diagnosis
Device Classification Information
| Device Type ID | 3537 |
| Device Name | Dengue Serological Reagents |
| Physical State | Kits |
| Technical Method | Immunological Method/ELISA |
| Target Area | Human Serum |
| Regulation Description | Dengue Virus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3945 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSU |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3537 |
| Device | Dengue Serological Reagents |
| Product Code | OSU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Dengue Virus Serological Reagents. |
| CFR Regulation Number | 866.3945 [🔎] |
TPLC Last Update: 2019-04-02 20:31:56