Duns Number:341714388
Device Description: AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cel AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
Catalog Number
51.101.US
Brand Name
AESKUSLIDES® ANA-HEp-2 gamma
Version/Model Number
51.101.US
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120889
Product Code
DHN
Product Code Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Public Device Record Key
68b6b153-ddc6-4cef-b0d5-2e34083ae028
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 28, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |