Device Type ID | 3252 |
Device Name | Antigen, Cf, Lymphocytic Choriomeningitis Virus |
Regulation Description | Lymphocytic Choriomeningitis 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) Exempt |
CFR Regulation Number | 866.3360 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | GQK |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |