Definition: Automated System Consisting Of A Fluorescence Microscope And Software That Acquires, Analyzes, Stores And Displays Digital Images Of Stained Indirect Immunofluorescent Slides. It Is Intended As An Aid In The Detection And Classification Of Certain An
| Device Type ID | 3104 |
| Device Name | Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use |
| Physical State | The System May Include A Fluorescence Microscope With Light Source, A Motorized Microscope Stage, Dedicated Instrument Controls, A Camera, A Computer, A Sample Processor, And Other Hardware Components. The Software May Include Fluorescent Signal Acqu |
| Technical Method | Indirect Immunofluorescent Technology |
| Target Area | Human Serum |
| Regulation Description | Automated Indirect Immunofluorescence Microscope And Software-assisted System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.4750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PIV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3104 |
| Device | Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use |
| Product Code | PIV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Indirect Immunofluorescence Microscope And Software-assisted System. |
| CFR Regulation Number | 866.4750 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INOVA DIAGNOSTICS, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |