Device Type ID | 3177 |
Device Name | Antisera, All Types, Shigella Spp. |
Regulation Description | Shigella Spp. 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 | 866.3660 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | GNB |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3177 |
Device | Antisera, All Types, Shigella Spp. |
Product Code | GNB |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Shigella Spp. Serological Reagents. |
CFR Regulation Number | 866.3660 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Remel Inc | II | Dec-26-2017 |