Product code PIV— Immunology
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
- Classification name
- Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
- Device class
- Class 2
- Regulation
- 21 CFR 866.4750
- Advisory panel
- Immunology
- Total cleared
- 2
- First cleared
- Most recent
FDA classification 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.”
Market context for product code PIV
FDA has cleared devices under product code PIV, all in 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code PIV
Recent clearances under product code PIV
Data sourced from openFDA. This site is unofficial and independent of the FDA.