Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
FDA product code PIV · Class II (moderate risk) · 21 CFR 866.4750 · Immunology
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.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153150 | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000PIV · Special | Inova Diagnostics, Inc. | 11/24/2015SE |