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PIVClass II

Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

21 CFR 866.4750 / Immunology
FDA source (opens on fda.gov)

PIV is the FDA product code for Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use, a class II device type, regulated under 21 CFR 866.4750. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PIV
Device name
Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
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.
Regulation
21 CFR 866.4750
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code PIV

By decision year
2 clearances under product code PIV with a decision year between 2015 and 2015, 2015 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PIV by decision year
YearClearances
20152

Applicants with the most clearances

Product code PIV
Applicants holding the most 510(k) clearances under product code PIV
ApplicantClearances
Inova Diagnostics, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code