Duns Number:188354831
Device Description: NOVA View® Automated Fluorescent Microscope is an automated system consisting of a fluores NOVA View® Automated Fluorescent Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. Optional AutoLoader available as an accessory.
Catalog Number
-
Brand Name
NOVA View®
Version/Model Number
NV2000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN140039,K153150
Product Code
PIV
Product Code Name
Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
Public Device Record Key
3d35554d-f095-4e2d-80e7-ffe52a2fecb7
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 215 |