Duns Number:341702675
Device Description: Automated system for immunofluorescence processing with an integral fluorescence microscop
Catalog Number
IOS-1000
Brand Name
HELIOS
Version/Model Number
AUTOMATED IFA SYSTEM
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
-
Product Code
DHN
Product Code Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Public Device Record Key
53c87a5d-6ffb-45c8-93f5-2517f770e335
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
March 02, 2020
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |