Device Type ID | 2406 |
Device Name | Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use |
Regulation Description | Blood Group Substances Of Nonhuman Origin For In Vitro Diagnostic Use. |
Regulation Medical Specialty | Hematology |
Review Panel | Hematology |
Premarket Review | Center For Biologics Evaluation & Research (CBER) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 864.9160 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KSX |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |