Duns Number:010558476
Device Description: The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory.
Catalog Number
63000
Brand Name
NOVEOS
Version/Model Number
Immunoassay Analyzer
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
K182479
Product Code
DHB
Product Code Name
System, Test, Radioallergosorbent (Rast) Immunological
Public Device Record Key
924cc5bb-e3bc-417f-8fa3-96ef2b0c556c
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
December 08, 2021
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 | 158 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 148 |