PIV
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.4750
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 (K153150) | Inova Diagnostics, Inc. | 2015-11-24 |
| NOVA View Automated Fluorescense Microscope (DEN140039) | Inova Diagnostics, Inc. | 2015-04-09 |
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