Plasmodium Spp. Detection Reagents
Device Code: 3523
Product Code(s):
OAX Definition: For The Detection Of Plasmodium Spp. Antigens In Venous Or Capillary Whole Blood. To Aid In The Diagnosis Of Human Malaria Infections And/or To Aid In The Differential Diagnosis Of Plasmodium Falciparum Infections From Other Less Virulent Plasmodium
Device Classification Information
| Device Type ID | 3523 |
| Device Name | Plasmodium Spp. Detection Reagents |
| Physical State | In Vitro Diagnostic Kit |
| Technical Method | In Vitro Diagnostic Immunochromatographic Membrane Assays Or Lateral Flow Assays That Uses Antibodies To Detect Specific Antigens. |
| Target Area | Plasmodium Spp. Antigens In Whole Blood |
| Regulation Description | Plasmodium Species Antigen Detection Assays. |
| 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 | 866.3402 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OAX |
| 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 | 3523 |
| Device | Plasmodium Spp. Detection Reagents |
| Product Code | OAX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Plasmodium Species Antigen Detection Assays. |
| CFR Regulation Number | 866.3402 [🔎] |
TPLC Last Update: 2019-04-02 20:31:41