PIV — Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use Class II
Classification Details
- Product Code
- PIV
- Device Class
- Class II
- Regulation Number
- 866.4750
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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 antibodies by indirect immunofluorescent technology. A trained operator must confirm all device generated results.