Device Type ID | 3166 |
Device Name | Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. |
Regulation Description | Entamoeba Histolytica Serological Reagents. |
Regulation Medical Specialty | Microbiology |
Review Panel | Microbiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 866.3220 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | GMO |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |