Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
The Automated Indirect Immunofluorescence Microscope and Software-Assisted System is an automated diagnostic platform that acquires, analyzes, stores, and displays digital images of indirect immunofluorescent slides, intended as an aid in the detection and classification of certain antibodies, with all results requiring confirmation by a trained operator. It is an FDA Class 2 device regulated under 21 CFR 866.4750, requiring 510(k) premarket notification, within the Immunology (IM) specialty. The product code is PIV, and it is eligible for third-party review.
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Basic Information
- Product Code
- PIV
- Device Class
- FDA class 2
- Regulation Number
- 866.4750
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.